On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials.
It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.
The Draft Guidance is among the deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.
ASBM’s comments reflected observations from ASBM Chair Madelaine Feldman, MD; Advisory Board Chair Philip Schneider MS, FASHP, FFIP; and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association. From the comments:
One thing we’ve seen across Europe is that as more and more biosimilars are launched in a given product class, competition drives prices downward, discounts increase substantially, and biosimilar market share goes up. So we know what to expect, and what things to look for.
Thankfully we are seeing this happening in the US. Here we have a biosimilar filgrastim that launched with a relatively low 15% discount over its reference product. Today, with increased competition, that product has attained a majority share of the US market in its class with 55%. Late last year we saw the first rituximab biosimilar launch at a 10% discount over the reference product, and only a few months later the second launched at a larger, 24% discount.
We have every reason to believe this pattern will continue as we see it becoming routine for 3, 4, or 5 biosimilars approved for a reference product, and as these come on the market, manufacturers will continue to compete on price- moving from low discounts, to higher discounts.
ASBM representatives participated in a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters to discuss the guidance; as well as a related half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day, entitiled “Biosimilars: Breaking through the Barriers’.
On March 25th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a whitepaper entitled Policy recommendations for a sustainable biosimilars market: lessons from Europe. The paper was authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider.
The biosimilar market in Europe is the largest in the world, representing approximately 60% of global biosimilar use. Several studies, research papers and position statements have been published that offer insight into elements that led to the successful introduction of biosimilars into Europe. The whitepaper examines these studies, along with real-world policy and procurement examples from European countries.
When comparing the findings and recommendations from these papers, several key conditions to achieve sustainable biosimilar markets can be identified and may be considered as ‘must haves’ for the long-term success of these markets. These are:
Physicians should have the freedom to choose between off-patent originator biologicals and available biosimilars and to act in the best interest of their patients based on scientific evidence and clinical experience.
Tenders should be designed to include multiple value-based criteria beyond price, e.g. education, services, available dose strengths, and provide a sufficient broad choice (multi-winner tenders versus single-winner tenders) to ensure continuity of supply and healthy competition.
A level playing field between all participating manufacturers is the best way to foster competition; mandatory discounts which place artificial downward pressure on manufacturers do not engender a sustainable market environment.
Reilly expressed his hope that the paper will aid in the international development of robust biosimilar markets:
“As countries around the world look to replicate the success of biosimilars in Europe, it is our hope that this paper will serve as a guide, identifying the common factors and specific policies embraced by many European countries which made that success possible.”
The paper will also appear in Volume 9, issue 2 of the Gabi Journal 2020 print edition to be published in June.
On March 9th and 10th, two major meetings were held in the nation’s capitol to discuss the barriers to the success of biosimilars in the U.S. marketplace.
The first meeting was a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters. The second was a half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day and featured a keynote address from Health and Human Services (HHS) Secretary Alex Azar.
ASBM representatives participated in both events. Dr. Feldman, Dr. Schneider, and Andrew Spiegel provided comments at the FDA/FTC meeting and posed questions to the panelists at the Hatch/Pfizer event.
A key theme at both meetings was the importance of educating physicians and patients about biosimilars, as well as addressing commercial barriers to biosimilar uptake posed by patent litigation, insufficient price transparency, and the PBM rebate system.
One presenter identified the chief barriers to biosimilar uptake as physicians (who needed educational outreach to increase their familiarity and comfort with biosimilars) and payers (whose policies can sometimes impede utilization, and need to be addressed). ASBM Advisory Board Chair Philip Schneider addressed these concerns in his remarks at the FDA/FTC workshop:
Our recent survey of 579 European biologic prescribers show high knowledge and high confidence in biosimilars. Depending on country, between 82% and 93% of prescribers considered themselves familiar or very familiar with biosimilars. Between 80% and 99% would feel comfortable prescribing a biosimilar to a new treatment-naïve patient. Between 46-76% would be comfortable switching a stable patient.
if the premise behind today’s proceedings is valid – that biosimilar uptake is strongly tied to physician confidence, the high physician confidence in biosimilars across the board should correlate with a consistently high uptake across the board.
Yet if we look at the biosimilar market shares across the six countries we surveyed, there is a very wide variation, and variation among biosimilars in different product classes. For example, market share for the Epoetin biosimilar ranged from 6-84%. There are similar ranges for other biosimilars.
Clearly there are other factors besides physician confidence, which is uniformly high across the countries. These factors likely include differences between each country’s payer policies, differences in the length of time a biosimilar has been on the market, the number of biosimilars in a given product class, the discount of each product relative to the originator product, and other factors.
ASBM Steering Committee Member Andrew Spiegel, who attended both events, characterized the U.S. biosimilars market as “a success story” in his remarks at the Hatch/Pfizer event. In addition to the Zarxio example, Spiegel also cited the example of the first rituximab biosimilar launched last year by Teva with a 10% discount. The second one, he pointed out, launched last month by Pfizer, has a 22% discount.
“As we look to Europe as a model, we see the key is many different products competing and putting downward pressure on price. The greater the discounts, the greater the market share- it’s encouraging to see this beginning to happen in the U.S. as well,” said Spiegel.
On March 9th and 10th, two major meetings were held in the nation’s capitol to discuss the barriers to the success of biosimilars in the U.S. marketplace.
The first meeting was a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters. The second was a half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day and featured a keynote address from Health and Human Services (HHS) Secretary Alex Azar.
ASBM representatives participated in both events. Dr. Feldman, Dr. Schneider, and Andrew Spiegel provided comments at the FDA/FTC meeting and posed questions to the panelists at the Hatch/Pfizer event.
A key theme at both meetings was the importance of educating physicians and patients about biosimilars, as well as addressing commercial barriers to biosimilar uptake posed by patent litigation, insufficient price transparency, and the PBM rebate system.
One presenter identified the chief barriers to biosimilar uptake as physicians (who needed educational outreach to increase their familiarity and comfort with biosimilars) and payers (whose policies can sometimes impede utilization, and need to be addressed). ASBM Advisory Board Chair Philip Schneider addressed these concerns in his remarks at the FDA/FTC workshop:
Our recent survey of 579 European biologic prescribers show high knowledge and high confidence in biosimilars. Depending on country, between 82% and 93% of prescribers considered themselves familiar or very familiar with biosimilars. Between 80% and 99% would feel comfortable prescribing a biosimilar to a new treatment-naïve patient. Between 46-76% would be comfortable switching a stable patient.
if the premise behind today’s proceedings is valid – that biosimilar uptake is strongly tied to physician confidence, the high physician confidence in biosimilars across the board should correlate with a consistently high uptake across the board.
Yet if we look at the biosimilar market shares across the six countries we surveyed, there is a very wide variation, and variation among biosimilars in different product classes. For example, market share for the Epoetin biosimilar ranged from 6-84%. There are similar ranges for other biosimilars.
Clearly there are other factors besides physician confidence, which is uniformly high across the countries. These factors likely include differences between each country’s payer policies, differences in the length of time a biosimilar has been on the market, the number of biosimilars in a given product class, the discount of each product relative to the originator product, and other factors.
ASBM Steering Committee Member Andrew Spiegel, who attended both events, characterized the U.S. biosimilars market as “a success story” in his remarks at the Hatch/Pfizer event. In addition to the Zarxio example, Spiegel also cited the example of the first rituximab biosimilar launched last year by Teva with a 10% discount. The second one, he pointed out, launched last month by Pfizer, has a 22% discount.
“As we look to Europe as a model, we see the key is many different products competing and putting downward pressure on price. The greater the discounts, the greater the market share- it’s encouraging to see this beginning to happen in the U.S. as well,” said Spiegel.
From March 2-4, ASBM representatives led multiple sessions at the World Biosimilar Congress USA, part of the Festival of Biologics USA 2020 held in San Diego, CA.
ASBM Steering Committee Member Andy Spiegel, executive director of the Global Colon Cancer Association, participated in an opening “fireside chat” with Leah Christl, PhD. Dr. Christl formerly led the FDA’s Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs (OND). Mr. Spiegel also moderated a panel discussion on “How to build a sustainable biosimilars market.”
ASBM Advisory Board Chair Philip Schneider, MS, FASHP moderated a panel discussion on “What do policymakers need to address for biosimilars to become more accessible?” and chaired a session on “Biosimilars in healthcare policy.” Topics examined in these sessions included: “Do biosimilars create real competition?” “Reimbursement in biosimilars;” and “Originators and biosimilars: getting the balance right.”
Following the conference, Dr. Schneider offered the following observations on the various discussions:
The US is catching up to the EU in the approval of both biologics and biosimilars, despite Europe’s nearly 10-year lead.
Biosimilars are beginning to place downward pressure on the prices of biologics; both reference products and biosimilars. Metrics for success are prices, not market share.
There is agreement on the importance of sustainability in the biologics and biosimilars market to promote innovation and competition. Multi-product tenders are one way to support this.
Prescriber choice remains an important issue among most players.
Learn more about the World Biosimilar Congress USA 2020 Meeting here.
Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
FDA Enhances Purple Book to Support Transparency in Biosimilars
On February 24th, the FDA announced that it will be upgrading the Purple Book, otherwise known as the “Database of FDA-Licensed Biological Products,” in phases. The updates will include full search functionality for all approved biosimilar products and their reference products. Subsequent phases are expected to expand the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products. FDA Commissioner Stephen M. Hahn, M.D. said of the update:
“This expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.
“We’re confident these enhancements will meet the needs of a wide range of users, from providing a simple search for patients and consumers, to a more advanced search for prescribers, researchers and industry representatives that may have a need for more technical information.
“Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications.”
ASBM Conducts 4th 5-Hour CE Course for NY Pharmacists
On February 23rd, ASBM presented a Continuing Education (CE) course entitled “Biosimilars- What’s New in 2020?“ to a gathering of more than 75 New York-area pharmacists.
The event took place at the LaGuardia Marriott in East Elmhurst, NY and was hosted by ASBM and Long Island University College of Pharmacy (LIU-Pharmacy). This is the fourth time ASBM has presented a course on biosimilars with LIU-Pharmacy; read about previous courses here: March 2015, November 2016, and September 2018.
The five-hour program consisted of seven presentations, each focusing on an important aspect of biosimilars:
ASBM Advisory Board Chair Philip Schneider gave presentations on the basics of biologic and biosimilar medicines; biologic naming and international harmonization efforts; why pharmacists should care about biosimilars; and comparing US biosimilar substitution policy among those of other advanced countries.
ASBM Chair Madelaine Feldman, MD, FACR provided a physician perspective on these issues, and supported her comments with recent survey data from prescribers in the U.S. and Europe regarding biologic naming and substitution policies.
ASBM Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association, provided a patient advocate’s perspective on biosimilars, with an emphasis on the issue of non-medical switching.
Dan Tomaszewski, PhD, PharmD, Assistant Professor at Chapman University College of Pharmacy, examined the role of pharmacists in biosimilar use, and discussed pharmacist-specific considerations of dealing with PBMs, insurers, and patients.
Interspersed with these were five short videos featuring interviews with additional patients, physicians, and pharmacists. These included inaugural ASBM Chair Richard Dolinar, MD; Immediate Past Chair Harry Gewanter MD FACR; and ASBM Steering Committee member and patient advocate Kathleen Arntsen, CEO of the Lupus and Allied Diseases Association.
Read a detailed description of the program and view all the presentations and videos here.
ASBM, Gastrointestinal Society Submit Joint Comments on Canadian Pricing Proposal
On February 14th, ASBM and the Gastrointestinal Society jointly submitted formal comments on the Canadian Patented Medicine Pricing Review Board (PMPRB) Draft Guidelines, as part of a stakeholder consultation by the PMPRB. From the comments:
As advocates representing millions of Canadian patients, the Alliance for Safe Biologic Medicines (ASBM) appreciates the opportunity to comment on the PMPRB’s new Draft Guidelines. ASBM is a global alliance of patient advocacy organizations and physician societies, working to promote patient-centered biosimilar policies worldwide.
The Gastrointestinal Society is one of our leading Canadian members, and represents as many as 6 million Canadians with irritable bowel syndrome (IBS), more than 9 million with functional dyspepsia, as many as 8 million with chronic acid reflux (GERD), and an additional 233,000 suffering from chronic inflammatory bowel disease (Crohn’s and ulcerative colitis).
We are keenly aware of the importance to the patients we represent of increasing access to new and innovative life-improving and life-extending therapies by ensuring affordability of these medicines.
However, pricing policies alone do not guarantee access; other factors contribute as well. Ensuring that new medicines available to patients in other advanced countries are launched in Canada as well is among these key factors.
It is our view that while well-intentioned, the new Draft Guidelines have a strong potential to upset this critical balance, by disincentivizing manufacturer investment in product launches and dissuading applications for subsequent indications in Canada, thereby jeopardizing, rather than promoting, patient access to such therapies.
Read ASBM’s and the Gastrointestinal Society’s joint comments in their entirety here.
FDA Announces Increased Collaboration with FTC to Address Anti-Competitive Practices in Biosimilar Market.
On February 3rd, the U.S. Food and Drug Administration and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.
“Competition is key for helping American patients have access to affordable medicines. While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs” said FDA Commissioner Stephen M. Hahn, M.D. “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”
“Biologics are essential to the treatment of many serious illnesses. Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation,” said FTC Chairman Joseph Simons. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”
Draft Guidance and Comment Period
The FDA has published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.
These announcements are key deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.
The FDA is accepting comments from the public on the draft guidance from February 4 to April 6.
Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
FDA Enhances Purple Book to Support Transparency in Biosimilars
On February 24th, the FDA announced that it will be upgrading the Purple Book, otherwise known as the “Database of FDA-Licensed Biological Products,” in phases. The updates will include full search functionality for all approved biosimilar products and their reference products. Subsequent phases are expected to expand the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products. FDA Commissioner Stephen M. Hahn, M.D. said of the update:
“This expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.
“We’re confident these enhancements will meet the needs of a wide range of users, from providing a simple search for patients and consumers, to a more advanced search for prescribers, researchers and industry representatives that may have a need for more technical information.
“Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications.”
ASBM Conducts 4th 5-Hour CE Course for NY Pharmacists
On February 23rd, ASBM presented a Continuing Education (CE) course entitled “Biosimilars- What’s New in 2020?“ to a gathering of more than 75 New York-area pharmacists.
The event took place at the LaGuardia Marriott in East Elmhurst, NY and was hosted by ASBM and Long Island University College of Pharmacy (LIU-Pharmacy). This is the fourth time ASBM has presented a course on biosimilars with LIU-Pharmacy; read about previous courses here: March 2015, November 2016, and September 2018.
The five-hour program consisted of seven presentations, each focusing on an important aspect of biosimilars:
ASBM Advisory Board Chair Philip Schneider gave presentations on the basics of biologic and biosimilar medicines; biologic naming and international harmonization efforts; why pharmacists should care about biosimilars; and comparing US biosimilar substitution policy among those of other advanced countries.
ASBM Chair Madelaine Feldman, MD, FACR provided a physician perspective on these issues, and supported her comments with recent survey data from prescribers in the U.S. and Europe regarding biologic naming and substitution policies.
ASBM Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association, provided a patient advocate’s perspective on biosimilars, with an emphasis on the issue of non-medical switching.
Dan Tomaszewski, PhD, PharmD, Assistant Professor at Chapman University College of Pharmacy, examined the role of pharmacists in biosimilar use, and discussed pharmacist-specific considerations of dealing with PBMs, insurers, and patients.
Interspersed with these were five short videos featuring interviews with additional patients, physicians, and pharmacists. These included inaugural ASBM Chair Richard Dolinar, MD; Immediate Past Chair Harry Gewanter MD FACR; and ASBM Steering Committee member and patient advocate Kathleen Arntsen, CEO of the Lupus and Allied Diseases Association.
Read a detailed description of the program and view all the presentations and videos here.
ASBM, Gastrointestinal Society Submit Joint Comments on Canadian Pricing Proposal
On February 14th, ASBM and the Gastrointestinal Society jointly submitted formal comments on the Canadian Patented Medicine Pricing Review Board (PMPRB) Draft Guidelines, as part of a stakeholder consultation by the PMPRB. From the comments:
As advocates representing millions of Canadian patients, the Alliance for Safe Biologic Medicines (ASBM) appreciates the opportunity to comment on the PMPRB’s new Draft Guidelines. ASBM is a global alliance of patient advocacy organizations and physician societies, working to promote patient-centered biosimilar policies worldwide.
The Gastrointestinal Society is one of our leading Canadian members, and represents as many as 6 million Canadians with irritable bowel syndrome (IBS), more than 9 million with functional dyspepsia, as many as 8 million with chronic acid reflux (GERD), and an additional 233,000 suffering from chronic inflammatory bowel disease (Crohn’s and ulcerative colitis).
We are keenly aware of the importance to the patients we represent of increasing access to new and innovative life-improving and life-extending therapies by ensuring affordability of these medicines.
However, pricing policies alone do not guarantee access; other factors contribute as well. Ensuring that new medicines available to patients in other advanced countries are launched in Canada as well is among these key factors.
It is our view that while well-intentioned, the new Draft Guidelines have a strong potential to upset this critical balance, by disincentivizing manufacturer investment in product launches and dissuading applications for subsequent indications in Canada, thereby jeopardizing, rather than promoting, patient access to such therapies.
Read ASBM’s and the Gastrointestinal Society’s joint comments in their entirety here.
FDA Announces Increased Collaboration with FTC to Address Anti-Competitive Practices in Biosimilar Market.
On February 3rd, the U.S. Food and Drug Administration and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.
“Competition is key for helping American patients have access to affordable medicines. While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs” said FDA Commissioner Stephen M. Hahn, M.D. “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”
“Biologics are essential to the treatment of many serious illnesses. Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation,” said FTC Chairman Joseph Simons. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”
Draft Guidance and Comment Period
The FDA has published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.
These announcements are key deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.
The FDA is accepting comments from the public on the draft guidance from February 4 to April 6.
On February 23rd, ASBM presented a Continuing Education (CE) course entitled “Biosimilars- What’s New in 2020?” to a class consisting of more than 75 New York area pharmacists. The event took place at the LaGuardia Marriott in East Elmhurst, NY and was hosted by Long Island University College of Pharmacy (LIU-Pharmacy). This is the fourth time ASBM has presented a course on biosimilars with LIU-Pharmacy; read about previous courses here: March 2015, November 2016, and September 2018.
The course began with pre-course learning assessment questions presented by Joseph Bova, RPh, Director of Continuing Education for LIU-Pharmacy, and ASBM Advisory Board Chair Philip Schneider, MS FASHP FFIP. The program consisted of seven presentations, each focusing on one important aspect of biosimilars. Interspersed with these were five short videos featuring interviews with additional patients, physicians, and pharmacists, including inaugural ASBM Chair Richard Dolinar, MD; immediate past Chair Harry Gewanter MD FACR; and ASBM Steering Committee Member and patient advocate Kathleen Arntsen, CEO of the Lupus and Allied Diseases Association.
Presentation 1: Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines
In the first presentation, Dr. Schneider begins by explaining what biologic medicines are, how they were developed and approved, and how they are used to treat serious conditions including rheumatoid arthritis and cancer. He then explains safety, storage and handling considerations that result from the greater size, complexity, and sensitivity of biologics, relative to small molecule drugs.
He follows with a discussion of biosimilars, discussing differences between biosimilars and chemical generics- chief among them that biosimilars are not identical but only highly similar to their reference products. In addition, he discusses differences between the approval processes of generics, biosimilars, and originator biologics, emphasizing the importance of improved pharmacovigilance for products with abbreviated approval pathways.
Presentation 2: Physician Perspectives on Biosimilars Madelaine Feldman, MD, FACR Chair, Alliance for Safe Biologic Medicines
In this presentation, Dr. Feldman discusses physician perspectives on four key biosimilar policy issues affecting medical and pharmacy practice: Naming, Interchangeability and Substitution, Non-Medical Switching, and Increasing Biosimilar Uptake.
Dr. Feldman began with a discussion of ASBM, its surveys and its work bringing the patient, physician and pharmacist perspectives to regulators worldwide. This includes ASBM’s history of participations in the WHO INN Consultations and its recent discussion forums on biosimilar naming in which the WHO, FDA, and Health Canada participated.
Regarding naming, Dr. Feldman discussed the importance to physicians worldwide of distinct naming for all biosimilars. Support for distinguishable biologic naming varies from 68% to 94% depending on country and region. She noted that significant percentages of physicians globally use the nonproprietary name when recording the prescribed biologic medicine in the patient record, which could result in the patient receiving the wrong medicine. Similarly, significant percentages of physicians worldwide use only the nonproprietary name when recording adverse events; which could result in their misattribution to the incorrect product.
Regarding substitution, Dr. Feldman emphasized the importance to physicians of communication from the pharmacist in the event of a biosimilar substitution; and of retaining the authority to prevent a substitution they deem medically inappropriate by using “dispense as written” (DAW). She also clarified that the U.S.-specific standard of “interchangeability”-applied to biosimilars suitable for pharmacy-level substitution- is not intended to be transitive. That is to say, even if biosimilar A and biosimilar B are both interchangeable with the same reference product, they are not interchangeable with each other. Dr. Feldman also discussed physician concerns with the non-medical switching of patients on biologics- switching these patients’ medicine for non-medical reasons. This is typically done by an insurer or PBM for cost or other financial reasons. Treatment decisions, including which biologic to use and if and when to switch, should be made by the patient in consultation with his or her healthcare team, rather than a third party payer, Dr. Feldman emphasized. She also discussed the example of two Canadian provinces which have recently begun the mass non-medical switching of thousands of their patients, and how the gastroenterologist community in particular has responded and expressed its concerns with this policy.
Dr. Feldman shared data from ASBM’s recent survey of 579 European prescribers of biologics, which showed these prescribers have high confidence in biosimilars, but nevertheless consider it extremely important to retain physician and patient control over treatment decisions: A strong majority of respondents (82%) considered it “Very Important” or “Critical” to decide which biologic medicine is dispensed to their patients, an increase from 72% in the 2013 survey. In addition, 84% consider the authority to prevent a substitution either “Very Important” or “Critical”, an increase from 74% in the 2013 survey. While 84% of physicians were comfortable prescribing biosimilars to new patients, the comfort level drops to 60% when switching stable patients to a biosimilar. 58% of physicians were uncomfortable switching patients to a biosimilar for economic rather than health reasons. If the non-medical switch were made by a third party, 73% would be uncomfortable.
Finally, Dr. Feldman discussed ways to increase biosimilar uptake- including an explanation of the physician’s cautious approach to choosing a medicine. Data showing safe use and safe switching of stable patients, she noted, are critical to building physician confidence. Distinct naming also reassures physicians that these products can be used safely and their effects tracked accurately.
Yet many of the obstacles to biosimilar uptake are commercial, and more approvals and lower cost does not translate to greater access for patients. For example, while 26 biosimilars are approved, only about half are currently available.
Patent litigation is common, which can result in delayed introduction of biosimilars. Finally, manufacturer rebate arrangements mean that PBMs may not give the lowest cost product preferred placement, posing a further- and more significant- barrier to uptake.
Presentation 3: Biologic and Biosimilar Naming: Pharmacist Perspectives and International Harmonization Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines
In this presentation, Dr. Schneider discussed considerations in the naming of biologics, including biosimilars, and the benefits of distinct naming. He described naming systems in use around the world, including the FDA’s four-letter suffix system, and the WHO’s proposed biologic qualifier or “BQ” system, which would also use a four-letter suffix if implemented. He shared survey data from ASBM and the Academy of Managed Care Pharmacy showing strong support among US pharmacists for distinct naming. He discussed the importance of having multiple, redundant layers of “defenses” in pharmacovigiliance and how this concept can be applied to distinct naming, and how different regulators around the world are approaching this problem, with varying degrees of effectiveness.
He also examined the benefits of and progress toward international harmonization of biologic nomenclature, including ASBM’s work with the WHO’s INN Programme. He highlighted perspectives gathered at ASBM’s April 2018, July 2018, and March 2019 forums at which FDA , Health Canada, WHO, and other stakeholders met to discuss the need for harmonization. Finally, Dr. Schneider discussed his work with the International Pharmaceutical Federation (FIP) which has begun addressing the issue of distinct biologic naming in its policy guidelines and its educational sessions.
Presentation 4: Why Should Pharmacists Care About Biosimilars?
Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines
In this presentation, Dr. Schneider examines why biosimilars are relevant to the pharmacy profession. First, he examines rising drug costs, much of which are driven by the cost of biologic medicines. Biosimilars, he explains, can be a tool to control these costs. However, biosimilars are not generics, and savings are not as high as with generics. In addition, significant discounts are not automatic- it is important to maintain competition between multiple products. Lessons from European biosimilar markets show this creates downward pressure on prices, without disincentivizing either innovator of biosimilar production. Other issues raised were the declining autonomy of healthcare professionals- where gag orders, preferential treatment of products by payers, or other financial incentives such as gain-sharing can distort the normal process of treatment decision-making. Dr. Schneider believes that the role of health care providers is to act as “learned intermediaries” in treatment decision-making. In effect, they are able to balance patient-specific factors against the the considerations of broad populations of patients- which are the primary focus of government regulators and private payers.
Presentation 5: Biosimilars: The Patient Advocate’s Perspective Andrew Spiegel Executive Director, Global Colon Cancer Association
Mr. Spiegel spoke about his experience as a patient advocate following the death of his parents from cancer. Today, he explained, the life expectancy of patients diagnosed with colon cancer has tripled, in part due to biologic medicines. Biosimilars, Mr. Spiegel emphasized, hold great promise for patients- offering new therapeutic options and doing so at lower cost. However, he cautioned that the benefits of biosimilars will not be realized unless they gain the confidence of providers and patients.
A key topic Mr. Spiegel discussed is Non-Medical Switching. The choice to use an innovator biologic or biosimilar, must always be made by the patient and physician, rather than a third-party payer.
“Treatment decisions, including the decision to switch from one medicine to another should be made for medical reasons that benefit the health and safety of the patient, not for non-medical reasons that might benefit a a company’s shareholders”, said Spiegel. He then outlined practices that payers may use to force a patient to switch to a non-interchangeable biosimilar, such as changing their medical coverage or health care premiums.
He also discussed the situation in Canada, where two provinces recently announced that they would be forcibly switching 50,000 patients from the medicine they and their physicians chose to a government-chosen biosimilar. “This is not how patients in Europe are treated. In nearly every country, new patients are encouraged to try the lower-cost biosimilar, but the physician and patient choose the medicine they want, and the payer will continue to reimburse it.”
Pharmacists, Spiegel said, serve an important role in patient care and should be well-informed by transparent, informative product labeling regarding a biosimilar’s approval, especially regarding indication extrapolation: “Pharmacists are the last line of defense for patients, the last link in the chain…they should give informed advice to patients about the benefits of biosimilars, as well as helping track possible adverse events.”
Video 4: Non-Medical Switching: What to Physicians and Patients Think?
Video 5: Pharmacists and Non-Medical Switching
Presentation 6: Biosimilar Substitution: A Collaborative Approach to Pharmacovigilance
Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines
The next presentation was given by Dr. Schneider, and dealt with biosimilar substitution policy in the United States. Dr. Schneider emphasized that while Congress sets the legal definition of interchangeability, and the FDA makes the scientific determination of which biosimilars are interchangeable, it is the individual States that govern when and how a pharmacist can substitute an interchangeable biosimilar.
Following a brief discussion about substitution policy globally (including Canada, the EU, Latin America, and Australia) Dr. Schneider spoke about the evolution of biosimilar substitution legislation in the US.
He focused his discussion on laws passed by 46 states and Puerto Rico which require a pharmacist to communicate to the prescribing physician which product- the originator or the biosimilar- was actually dispensed to the patient. These states also allow a physician to specify “do not substitute” or “dispense as written” in order to prevent a substitution they consider medically inappropriate.
A collaborative and communicative approach to pharmacovigilance, Schneider argued, is good for everyone. It empowers the pharmacist to offer the patient new and lower-cost treatment options, it allows the patient to be an engaged partner in a their own care, it allows the physician to maintain an accurate patient record and make informed treatment decisions, and it improves safety overall by promoting accurate attribution of adverse events to the proper medicine.
Presentation 7: Pharmacists and Biosimilars: The Role of Pharmacists in Managing Biosimilar Use Daniel Tomaszewski, RPh, Phd Assistant Professor in Pharmacy Administration, Chapman University
In this presentation, Dr. Tomaszewski discusses the role of pharmacists in collaboratively managing patient care regarding biologics. This includes managing prior authorizations from PBMs, and dealing with patient use concerns including ensuring adherence and increasing familiarity with biosimilars. He discussed his work with AMCP on a 2016 study that showed strong support for distinct names for biosimilars. He emphasized the importance of real world evidence (RWE) in building confidence in biosimilars, and the importance of pharmacists in gathering it.
Echoing the concerns of many physicians, Dr. Tomaszewski discussed the impact of post-approval barriers to biosimilar access including patent litigation and payer policies. He concluded with proposals on how to improve education on biosimilars, including a need to focus on providing fact driven data, to encourage better pharmacist engagement in specialty drug utilization, to ensure appropriate medicinal chemistry, pharmacologic, and therapeutic understanding of biologic agents, and to become knowledgeable about coverage/formulary/utilization management strategies likely to be put in place.
The course concluded with a Q+A session with a panel featuring all presenters, followed by a learning assessment in which attendees were quizzed about what they had learned throughout the five-hour program.
Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
ASBM Submits Comments in Canadian Biosimilar Stakeholder Consultation Period
On January 13th, the third and final phase of a stakeholder consultation on Canadian biosimilar policy closed. The consultation was conducted by the Canadian Agency for Drugs and Technologies and Health (CADTH), in conjunction with the pan-Canadian Pharmaceutical Alliance (pCPA) to develop recommendations for the use and implementation of biosimilars.
The first phase of the consultation included interviews with stakeholders; the second phase was an in-person consultation on November 18, 2019, and the third and final phase was an online survey, which closed on January 13, 2020.
ASBM submitted comments with other Canadian stakeholders in the patient and physician communities who are concerned with Canadian biosimilar policy. Michael Reilly, executive director of ASBM, summarized the group’s position:
Biosimilars can be a valuable tool in controlling health costs, but it is critical that treatment decisions continue to be made by patients and their physicians, not by politicians. This is particularly true in the case of patients who are well-treated and stable on their current medications.
Moreover, the economic benefits of biosimilars need not come at the cost of patients receiving the medicine their physician chooses to best meet their needs. European countries, for example, enjoy a robust and competitive biosimilars market, with significant savings.
Nearly every country in Europe will reimburse whichever biologic the physician prescribes – whether it’s an originator biologic or a biosimilar. No European country has a forced-substitution policy enacted by government fiat (as recently seen in British Columbia and Alberta.) We urge Canadian provinces to pattern their substitution practices on the patient-friendly, physician-centered, and pro-competition policies that have proven so successful in Europe.
FDA Highlights Biosimilar Approvals in 2019 Annual Report
In early January, The FDA’s Center for Drug Evaluation and Research’s (CDER) released its annual report, “Advancing Health Through Innovation: New Drug Therapy Approvals,” The report covers CDER’s notable new drug approvals and illustrates the Center’s role in bringing innovative new drug therapies that are safe and effective to patients in need.
CDER approved 48 novel medicines and 10 biosimilars during 2019, according to the report. Janet Woodcock, MD, director of CDER, praised the FDA’s success in biosimilar approvals, saying:
“Biosimilars have great potential for both patients and the entire health care system. As patents and exclusivity protections for biologics expire in the United States, we can expect many more biosimilars to be submitted for approval. More products on the market means greater competition that can lead to increased access to therapies and lower costs to patients.”
SInce its first approval in March 2015, the FDA has approved 26 biosimilars. The most recent approval, in December 2019, was for Avsola (infliximab-azzq), the fourth biosimilar for Remicade (infliximab).
Patient Advocates, Opposition Party Criticize Alberta Government’s Forced-Switch Policy
On January 15th, a dozen patient advocates gathered at the Alberta Federal Building to urge the government of Alberta to halt implementation of a controversial forced-biosimilar-substitution policy announced December 12th. Adult patients, except pregnant women, currently taking a biologic drug that has a biosimilar version for their medical condition must switch to the biosimilar drug before July 1, 2020. This mirrors a policy recently enacted in British Columbia which has drawn criticism from the Canadian Association of Gastrenterology and numerous patient organizations.
One patient expressed how she was “shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs”.
The patients were joined by Alberta’s NDP opposition health critic David Sheperd, who called on the government to reverse a policy he characterized as having been “botched” and which creates “a real risk for some of these folks of returning to be sick and incapacitated”.
“It’s important to introduce biosimilars (to new patients),” Sheperd said. “I recognize that there are indeed costs that we need to reckon with and I think it’s reasonable for government to move forward.
“My disagreement is with the manner in which it is moving forward: chaotic, rushed, not thought through, not considering long-term potential consequences.”
WHO Publishes Executive Summary of 69th INN Consultation
The World Health Organization recently published the Executive Summary of the 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, which took place on October 22nd, 2019 in Geneva, Switzerland.
ASBM participated in the Consultation, and was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. This was the thirteenth INN Consultation at which ASBM has presented.
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings on this topic with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June 2019.
The INN Committee’s Executive Summary of the Open Session for Stakeholders reflected several of the key points made in ASBM’s presentation, including:
A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively.
ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number.
Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.
[ASBM] felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now.
[ASBM] felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.
Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
ASBM Submits Comments in Canadian Biosimilar Stakeholder Consultation Period
On January 13th, the third and final phase of a stakeholder consultation on Canadian biosimilar policy closed. The consultation was conducted by the Canadian Agency for Drugs and Technologies and Health (CADTH), in conjunction with the pan-Canadian Pharmaceutical Alliance (pCPA) to develop recommendations for the use and implementation of biosimilars.
The first phase of the consultation included interviews with stakeholders; the second phase was an in-person consultation on November 18, 2019, and the third and final phase was an online survey, which closed on January 13, 2020.
ASBM submitted comments with other Canadian stakeholders in the patient and physician communities who are concerned with Canadian biosimilar policy. Michael Reilly, executive director of ASBM, summarized the group’s position:
Biosimilars can be a valuable tool in controlling health costs, but it is critical that treatment decisions continue to be made by patients and their physicians, not by politicians. This is particularly true in the case of patients who are well-treated and stable on their current medications.
Moreover, the economic benefits of biosimilars need not come at the cost of patients receiving the medicine their physician chooses to best meet their needs. European countries, for example, enjoy a robust and competitive biosimilars market, with significant savings.
Nearly every country in Europe will reimburse whichever biologic the physician prescribes – whether it’s an originator biologic or a biosimilar. No European country has a forced-substitution policy enacted by government fiat (as recently seen in British Columbia and Alberta.) We urge Canadian provinces to pattern their substitution practices on the patient-friendly, physician-centered, and pro-competition policies that have proven so successful in Europe.
FDA Highlights Biosimilar Approvals in 2019 Annual Report
In early January, The FDA’s Center for Drug Evaluation and Research’s (CDER) released its annual report, “Advancing Health Through Innovation: New Drug Therapy Approvals,” The report covers CDER’s notable new drug approvals and illustrates the Center’s role in bringing innovative new drug therapies that are safe and effective to patients in need.
CDER approved 48 novel medicines and 10 biosimilars during 2019, according to the report. Janet Woodcock, MD, director of CDER, praised the FDA’s success in biosimilar approvals, saying:
“Biosimilars have great potential for both patients and the entire health care system. As patents and exclusivity protections for biologics expire in the United States, we can expect many more biosimilars to be submitted for approval. More products on the market means greater competition that can lead to increased access to therapies and lower costs to patients.”
SInce its first approval in March 2015, the FDA has approved 26 biosimilars. The most recent approval, in December 2019, was for Avsola (infliximab-azzq), the fourth biosimilar for Remicade (infliximab).
Patient Advocates, Opposition Party Criticize Alberta Government’s Forced-Switch Policy
On January 15th, a dozen patient advocates gathered at the Alberta Federal Building to urge the government of Alberta to halt implementation of a controversial forced-biosimilar-substitution policy announced December 12th. Adult patients, except pregnant women, currently taking a biologic drug that has a biosimilar version for their medical condition must switch to the biosimilar drug before July 1, 2020. This mirrors a policy recently enacted in British Columbia which has drawn criticism from the Canadian Association of Gastrenterology and numerous patient organizations.
One patient expressed how she was “shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs”.
The patients were joined by Alberta’s NDP opposition health critic David Sheperd, who called on the government to reverse a policy he characterized as having been “botched” and which creates “a real risk for some of these folks of returning to be sick and incapacitated”.
“It’s important to introduce biosimilars (to new patients),” Sheperd said. “I recognize that there are indeed costs that we need to reckon with and I think it’s reasonable for government to move forward.
“My disagreement is with the manner in which it is moving forward: chaotic, rushed, not thought through, not considering long-term potential consequences.”
WHO Publishes Executive Summary of 69th INN Consultation
The World Health Organization recently published the Executive Summary of the 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, which took place on October 22nd, 2019 in Geneva, Switzerland.
ASBM participated in the Consultation, and was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. This was the thirteenth INN Consultation at which ASBM has presented.
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings on this topic with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June 2019.
The INN Committee’s Executive Summary of the Open Session for Stakeholders reflected several of the key points made in ASBM’s presentation, including:
A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively.
ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number.
Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.
[ASBM] felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now.
[ASBM] felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.
Patent litigation is common, which can result in delayed introduction of biosimilars. Finally, manufacturer rebate arrangements mean that PBMs may not give the lowest cost product preferred placement, posing a further- and more significant- barrier to uptake.
He also discussed the situation in Canada, where two provinces recently announced that they would be forcibly switching 50,000 patients from the medicine they and their physicians chose to a government-chosen biosimilar. “This is not how patients in Europe are treated. In nearly every country, new patients are encouraged to try the lower-cost biosimilar, but the physician and patient choose the medicine they want, and the payer will continue to reimburse it.”
Pharmacists, Spiegel said, serve an important role in patient care and should be well-informed by transparent, informative product labeling regarding a biosimilar’s approval, especially regarding indication extrapolation: “Pharmacists are the last line of defense for patients, the last link in the chain…they should give informed advice to patients about the benefits of biosimilars, as well as helping track possible adverse events.”
