ASBM Releases Preliminary Findings from European Prescribers Survey at ESMO 2019

October 1, 2019

September 30, 2019 – Barcelona, Spain – The Alliance for Safe Biologic Medicines (ASBM) this week shared preliminary findings from a survey of 575 biologic prescribers in six Western European countries, covering several key policy issues including biosimilar substitution practices, adverse event reporting, and government tendering criteria. Since 2010, the group has routinely surveyed physicians in 13 countries to gather empirical data that can serve as a guide to policymakers on how to increase physician confidence in biosimilars.

The results were presented in a poster and discussion session at the 2019 Congress of the European Society of Medical Oncology (ESMO 2019). Survey respondents were drawn in equal proportion from France, Germany, Italy, Spain, Switzerland, and the United Kingdom. They came from 10 practice areas: Dermatology, Endocrinology, Gastroenterology, Hematology Oncology, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, and Rheumatology. The survey is a follow-up to the group’s 2013 survey of 479 European prescribers.
One policy issue examined in the survey is physician control over biologic treatment decisions, including automatic  substitution and non-medical-switching. As governments worldwide seek to control health costs, use of lower cost biosimilars can be an effective tool. Yet unlike generics, biosimilars are not identical copies of the originator product. For this reason, automatic substitution of biologics is rare, and indeed banned in the majority of European Union countries.
“With 13 years of experience prescribing biosimilars, Europe’s physicians have become most knowledgeable and familiar with biosimilars in the world,” said Michael Reilly, executive director of ASBM and poster co-author. While 76% of physicians considered themselves familiar with biosimilars in the 2013 survey, that figure has risen to 90% in 2019.

Mr. Reilly presented the poster at ESMO with fellow co-author Andrew Spiegel, executive director of the Global Colon Cancer Association. “Countries looking to duplicate Europe’s success with biosimilars may look to these results for guidance. Note that the importance of maintaining physician and patient control of treatment decisions – including the decision to switch a stable patient to a biosimilar – has also increased since they were last surveyed six years ago,” said Mr. Reilly.

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 decision to do so were made by a third party, 73% would be uncomfortable.

The ability to choose between several different medicines was also highly important to prescribers: With regard to the awarding of government tenders, a majority of respondents (63%) feel that it is either “Very Important” or “Critical” that tenders to be awarded to multiple suppliers. 83% feel that it is either “Very Important” or “Critical” for national tender offers to consider factors besides price.

“While comfortable with prescribing biosimilars, Europe’s physicians want to have multiple options to choose from, so they can make the best medical decision for their patients – whether that’s the originator product, or one of its biosimilars,” emphasized Mr. Spiegel.
ASBM will be sharing the full results of the survey in a series of meetings with regulators throughout Europe this fall. This will include sharing country-specific data with several national health ministries, as was done with ASBM’s 2013 survey.

View the ESMO poster here.

Contact: Media@safebiologics.org
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Biosimilars Working Group Responds to Phase II of the BC PharmaCare Biosimilars Initiative

September 23, 2019

Biosimilars Working Group Responds to Phase II of the BC PharmaCare Biosimilars Initiative

VANCOUVER, BC – Wednesday, September 18, 2019. On September 5, 2019, the BC government announced phase two of its Biosimilars Initiative, informing patients prescribed the originator biologic drug, Remicade® (infliximab), to treat inflammatory bowel disease (Crohn’s disease and ulcerative colitis) that this medication will no longer be covered by the province, and that they must switch to a biosimilar infliximab, either Inflectra® or Renflexis®.1 This means that patients have only six months to meet with their gastroenterologist to discuss switching their medication and to start a replacement product. The sweeping change in coverage is driven by the government’s decision to generate significant healthcare savings from switching patients’ medication rather than negotiating with the makers of the originator biologic to lower their prices.

Biologics are medicines created from living cells and are used to treat a variety of conditions, such as Crohn’s disease, ulcerative colitis, diabetes, rheumatoid arthritis, cancer, osteoporosis, psoriasis, HIV, multiple sclerosis, and growth deficiencies, to name a few. Biosimilars are highly similar to an originator biologic, but different enough to be sold under their own brand name. Because these drugs are made from living cells, it is impossible to create an identical copy regardless of the use of the exact same manufacturing conditions, ingredients, and process.2 This is a stark comparison to generic drugs, which are made up of chemicals that can be reproduced with the same active ingredient as the original brand name product.3

Health Canada considers a biosimilar to be safe, effective, and of good quality, and highly similar to the originator biologic it references. For a number of reasons, including that the biosimilar companies do not have to invest in discovery and clinical trials, these medicines provide lower-cost options for public payers. However, as the originator biologics are now off-patent, the companies that own these products are willing to negotiate lower prices. Unfortunately, public drug plans prefer to support a biosimilar market.

It is important to note that biosimilars, unlike generic medications, are not interchangeable with the innovator biologic medication. Health Canada set the bar, saying, “Biosimilars are not generic biologics and many characteristics associated with the authorization process and marketed use for generic pharmaceutical drugs do not apply. Authorization of a biosimilar is not a declaration of pharmaceutical equivalence, bioequivalence or clinical equivalence to the reference biologic drug.” Be wary of anyone who calls biosimilars “biogeneric”, as this is an unacceptable, made-up word for these products.

Health Canada further states that the treating physician, in consultation with the patient, should make the decision to switch a patient after taking into account available clinical evidence.

Canada is the only country in the world to have comprehensive patient support programs paid for by the pharmaceutical companies. This means patients receiving intravenous infusions will need to switch to another group and location to receive their treatment, which could add further stress as they adjust to a new location of care and a new support staff.

The change in coverage is estimated to affect 1,700 patients. This is in addition to about 20,400 British Columbians diagnosed with ankylosing spondylitis, diabetes, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis affected from phase one of the Biosimilars Initiative. This population includes pediatric patients, while pregnant patients may be provided exceptional coverage following approval of request from PharmaCare’s Special Authority branch.4

The Biosimilars Working Group, a diverse cohort of health patient groups dedicated to ensuring the best outcomes for patients, welcomes the BC government’s expansion for access to healthcare services, such as full coverage for the fecal calprotectin test and increased funding for nursing support. However, the cost-driven objective of the forced-switch policy is worrisome as it fails to put physician wisdom, patient choice, appropriateness of care, accessibility, and affordability at the forefront of health policy. Patients should only switch if they decide that this is the best course of action for their conditions, with consultation from their treating physician.

Gail Attara, President & CEO of the Gastrointestinal Society, and member of the Biosimilars Working Group, shared that, “Every disease area is unique and each needs to be treated differently. Patients with limited therapeutic options should not be lumped together with those who have a broader range of options available to them. Many people depend on public coverage and only a select few have private health plans that do better.”5

Surveys conducted on various healthcare stakeholders, including patients, physicians, family caregivers, and the public, in Canada and abroad, reveal synonymous conclusions that treatment decisions should remain between a patient and their physician. Health Canada also encourages patients to speak with their treating physician about switching.6

In 2017, five patient organizations collaborated on a project that surveyed Canadian patients with inflammatory diseases about their perspectives on biologics and biosimilars. Of the 657 individuals surveyed, a vast majority reported being opposed to a forced switch for non-medical reasons.

“We are deeply concerned about the risks associated with a switch. Already, patients with loss of vision depend on accessibility and informed consent when being administered treatments. Furthermore, patients who are stable on a biologic treatment should not be made to potentially jeopardize their safety and quality of life with a mandated switch,” said Louise Gillis, National President of the Canadian Council of the Blind.

Biosimilars in oncology are expected to increase in the Canadian market and the implementations made by the BC government concern many cancer patients. “While we are aware of the value of biosimilars, the Canadian Cancer Survivor Network believes that patients who are being successfully treated by biologics should not be forced to switch. Any such decisions should be made by patients in consultation with their clinicians,” shared Jackie Manthorne, President & CEO of the Canadian Cancer Survivor Network.

The BC Ministry of Health precipitates the need to increase biosimilar uptake due to best practices in the European market, having had over a decade of experience with these products. The Alliance for Safe Biologic Medicines (ASBM), an international and multi-stakeholder organization comprised of healthcare groups, patients, physicians, and biotechnology companies, responded to the BC announcement by releasing a fact sheet analyzing the claims purported by the provincial government.7 “European countries, for example, enjoy robust biosimilar markets and higher uptake rates, yet the vast majority leave the decision on what biologic medicine to use with the treating physician, in consultation with their patient. No country in Europe has ceased the reimbursement of originator biologics by a government decree such as that issued in BC and only very few countries use a procurement process that will reimburse a single product that wins the bid,” said Michael Reilly, Executive Director of ASBM.8

The Biosimilars Working Group will continue to raise the importance of patient choice and evidence-based decision making with policymakers. To stay up-to-date with biosimilars research and policies, please visit www.biosimilaroptions.ca and follow @BiosimilarsWG on Twitter.

About the Biosimilars Working Group:

The Biosimilars Working Group is a key collaboration of diverse non-profit organizations, registered health charities, and healthcare advocacy coalitions who are dedicated to ensuring that good outcomes for patients are at the centre of health policy in Canada, specifically in the biologic medication treatment areas. We create up-to-date and evidence-based educational material for patients and healthcare professionals as a basis to inform our advocacy work on behalf of the patients who we serve.

Working Group Members Participating in This Media Release:

Alliance for Safe Biologic Medicines
Canadian Cancer Survivor Network
Canadian Council of the Blind
Canadian Society of Intestinal Research
Gastrointestinal Society

For more information, please contact Gail Attara, president & chief executive officer of the Gastrointestinal Society, at gail [at] badgut.org, 604-873-4876.

1. Biosimilars Initiative for Patients. Province of British Columbia page. Available at: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients. Accessed 2019-09-11.
2. Biologics and Biosimilars. GI Society page. Available at: https://badgut.org/information-centre/a-z-digestive-topics/biosimilars-pamphlet/. Accessed 2019-09-11.
3. Biosimilar biologic drugs in Canada: Fact Sheet. Government of Canada page. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a17. Accessed 2019-09-11.
4. Biosimilars Initiative for Patients. Province of British Columbia page. Available at: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients. Accessed 2019-09-11.
5. Gail Attara, “Balancing Act: Cost Containment vs. Patient Health Outcomes,” GI Society Canadian Society of Intestinal Research, available at https://badgut.org/balancing-act/, Accessed 2019-09-11.
6. Biosimilar biologic drugs in Canada: Fact Sheet. Government of Canada page. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a17 Accessed 2019-09-11.
7. ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies. Alliance for Safe Biologic Medicines page. Available at: https://safebiologics.org/wp-content/uploads/2019/08/ASBM-Factsheet-BC-vs-EU-Substitution.pdf. Accessed 2019-09-11.
8. ASBM Raises Concerns for Patients as BC Gov’t Expands Biologics Forced-Switch Policy. Alliance for Safe Biologics page. Available at: https://safebiologics.org/2019/09/asbm-raises-concerns-for-patients-as-bc-govt-expands-biologics-forced-switching-policy/. Accessed 2019-09-12.

ASBM Raises Concerns for Patients as BC Gov’t Expands Biologics Forced-Switching Policy

September 11, 2019

Erosion of Physician and Patient Treatment Choice Continues – Alliance for Safe Biologic Medicines Raises Concerns for Patients as British Columbia Expands Biologics Forced Switching Policy

September 10, 2019

 

VANCOUVER, B.C.- On September 5th, the Government of British Columbia (BC) announced that it would be forcibly switching 1,700 patients with Inflammatory Bowel Disease (IBD) from their current biologic medicine to alternative versions of the treatment, the government’s choice of preferred “biosimilar” products, and cease the reimbursement of their current biologic medicine. The announcement follows a May 27th mandate that 20,700 arthritis, psoriasis, and diabetes patients would be forcibly switched from their existing medicines to the government’s choice of preferred biosimilar products. This forced switching policy was presented as a trade-off for the government’s agreement to grant reimbursement for new innovative medicines, although no new IBD medications have been added to the B.C. public formulary. The policy disregards important scientific considerations for patients on biologic medicines and most alarmingly, eliminates patient choice, according to the Alliance for Safe Biologic Medicines (ASBM).

ASBM is a global coalition of physicians and patient advocates, including 14 Canadian organizations and more than 50 European patient advocacy groups, that has worked closely with Canadian advocacy organizations in recent years to share physician and patient perspectives with policy makers.

Biologics are made using living cells and as a result, may inspire unwanted immune reactions. For that reason, changing from one product to another is widely considered to be a decision to be made by the treating doctor in consultation with the patient. Biosimilars are highly similar, but not identical, to the original medicines, thus, the forced switch of them is a rarity among advanced nations and banned throughout much of Europe and the United States.

“Biosimilar competition and the use of biosimilars can be an effective way to reduce health costs, but potential savings need not, and should not, override patient and physician control of treatment decisions” says ASBM executive director Michael Reilly. “European countries, for example, enjoy robust biosimilar markets and higher uptake rates, yet the vast majority leave the decision on what biologic medicine to use with the treating physician, in consultation with their patient. Switching from an originator to a biosimilar or between biosimilars remains a clinical decision best made by the treating physician.”

Higher uptake rates of biosimilars in Europe have been touted by B.C. Health Minister Adrian Dix as a rationale for the force-switching policy, but it is important to note that Europe has almost universally rejected forced switching as a cost-control mechanism, says Reilly: “No country in Europe has ceased the reimbursement of originator biologics by a government decree such as that issued in B.C. and only very few countries use a procurement process that will reimburse a single product that wins the bid.” He directs interested parties to a fact sheet developed by ASBM, which contrasts the B.C. policy to those of Europe and dispels misconceptions.

ASBM has twice conducted large-scale surveys of European physicians on biosimilar policy issues. In 2013, ASBM surveyed 479 prescribers in 5 countries, and shared the results with several Ministries of Health, the European Commission, and the World Health Organization as these regulators developed biosimilar policy. Results from a 2019 survey of 575 physicians in six countries will be released this fall.

Reilly emphasized the sharp contrast between the unique forced-switching policy of B.C. and biosimilar policies in Western Europe, which are built on the principles of education, competition, and physician autonomy:

“Nearly all of Western Europe allows physicians to choose between multiple competing products, while encouraging the voluntary prescribing of biosimilars. Only in Denmark and in a few Eastern European countries do we find forced biosimilar switching policies with physician and patient choice eliminated and only one product reimbursed. Canadian patients deserve first-rate health care; this policy moves them in the opposite direction and we respectfully urge the B.C. government to reconsider it.”

Other patient advocacy organizations have echoed these concerns. The Gastrointestinal Society, representing the quarter-million Canadians with IBD, released a statement supporting physician and patient control of treatment decisions: “While cost is an important factor for a sustainable healthcare system, when it comes to the selection of treatment, reimbursement policies must recognize and respect the physician’s right to prescribe based on clinical evidence and a patient’s right to choose the therapy that is best for them.” The statement also emphasized the organization’s belief “that the onus is on payers (government or private) to negotiate with manufacturers of innovative biologics and their biosimilars to protect options for patient care.”

According to the Better Pharmacare Coalition, a group composed of 28 B.C. based patient advocacy organizations and charities, “B.C. is one of the only jurisdictions paying list price [the price before negotiated rebates and discounts are applied] for Remicade® in Canada, as the negotiated listing price agreement ended and BC PharmaCare refuses to negotiate with the manufacturer on a discounted rate.”

Crohn’s and Colitis Canada, which recently conducted cross-Canada surveys of patients and caregivers, gastroenterologists and IBD nurses, also released a statement citing concerns with the B.C. policy. “Crohn’s and Colitis Canada is a research-based organization. We took the time to carefully review our position on biosimilars and particularly on related non-medical switching policy in order to represent our patients thoughtfully and responsibly,” says Mina Mawani, President and CEO of Crohn’s and Colitis Canada. “Our position that a non-medical switch policy is not in the best interest of patients is based on what we’ve learned these past few months.”

Canadian physicians surveyed have also expressed strong concerns: According to a 2017 survey of 403 Canadian biologic prescribers, 64% were not comfortable with a third party switching a patient’s biologic medicine for non-medical (e.g. cost) reasons. 83% considered it “very important” or “critical” that prescribing physicians decide the most suitable biologic for their patients.

“Physicians should have the option to prescribe biosimilars, or any other safe and effective biologic. What is at stake here is who gets to make that decision”, Reilly said. “Will it remain the physician and patient – as in Europe, the U.S., and most advanced nations – or will the government restrict choice and force stable patients to switch to a particular government -favored product du jour – whether it be an originator or a biosimilar?”

 

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ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies

August 5, 2019

As BC attempts to increase biosimilar use by force-switching 23,000 patients, Europe enjoys high uptake rates while preserving patient and physician choice. 

On August 5th, ASBM released a fact sheet contrasting the biosimilar substitution policies of European countries (which generally have robust biosimilar markets) with the newly announced British Columbia policy.
First fact sheet also addresses misconceptions about the market share of biosimilars in Europe. While the rates of biosimilar use for older biosimilars (those approved before 2013) can be as high as 91%, rates for biosimilars approved after 2013 vary from country to country, ranging from 0% to 43%. (All but one of the biosimilars approved in Canada fall into this latter group.)
In addition, in contrast to the BC policy, the vast majority of European countries leave the decision of what biologic medicine to use with the treating physician in consultation with their patient. 
Also, during the 13 years of experience with biosimilar medicines in European markets, no country has directed well-treated patients to either transition to a biosimilar or to change to a different biologic as a condition for the reimbursement of additional innovative drugs and to expand coverage of existing drugs.

 

ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies

August 5, 2019

As BC attempts to increase biosimilar use by force-switching 23,000 patients, Europe enjoys high uptake rates while preserving patient and physician choice. 

On August 5th, ASBM released a fact sheet contrasting the biosimilar substitution policies of European countries (which generally have robust biosimilar markets) with the newly announced British Columbia policy.
First fact sheet also addresses misconceptions about the market share of biosimilars in Europe. While the rates of biosimilar use for older biosimilars (those approved before 2013) can be as high as 91%, rates for biosimilars approved after 2013 vary from country to country, ranging from 0% to 43%. (All but one of the biosimilars approved in Canada fall into this latter group.)
In addition, in contrast to the BC policy, the vast majority of European countries leave the decision of what biologic medicine to use with the treating physician in consultation with their patient. 
Also, during the 13 years of experience with biosimilar medicines in European markets, no country has directed well-treated patients to either transition to a biosimilar or to change to a different biologic as a condition for the reimbursement of additional innovative drugs and to expand coverage of existing drugs.

 

June-July 2019 Newsletter

August 1, 2019

newsletter | June-July 2019
issue 79
 
 
 

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.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

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ASBM Statement on Prescription Drug Price Reduction Act (PDPRA)

 

On July 25th, the U.S. Senate Committee on Finance passed the Prescription Drug Pricing Reduction Act (PDPRA) of 2019, in a vote of 19-9. On July 29th, ASBM released a statement outlining concerns with one of the bill’s provisions. From the statement:

 

The stated aims of the bill include lowering prescription drug prices and boosting biosimilar uptake; these goals are shared by ASBM and many others in the physician and patient advocacy community. One provision in the PDPRA, however, raises serious concerns.

 

According to the bill, higher reimbursement rates will be paid to physicians who prescribe biosimilar biologic products under Medicare Part B than originator biologic products. If implemented, this plan to provide the doctor a 33% bonus for use of a biosimilar would insert financial incentives where patient interests should prevail. Every patient should be confident that their physician will prescribe the product that is in their best interest…not the one that is the most profitable to the physician personally. This proposed scheme fundamentally undermines the patient-physician relationship of trust.

 

ASBM’s position has been and continues to be that treatment decisions should be based on what is best for the patient, unfettered by third-party influence. That decision should take into consideration a number of factors, including the affordability of the drug for the patient, not profit for the physician.

 

 

Read the full statement here. 
Two New Biosimilars Available in US in July

On July 19th, biologics manufacturers Amgen and Allergan announced that the biosimilars Mvasi® (bevacizumab-awwb) and Kanjinti® (trastuzumab-anns), which reference Roche cancer drugs Avastin® (bevacizumab) and Herceptin® (trastuzumab), respectively, are now available in the US.
“As the first products from our collaboration with Amgen to be launched in the country, Mvasi® and Kanjinti® reinforce our ongoing dedication to providing patients with additional treatment options,” said David Nicholson, chief R&D officer at Allergan.
The drugmakers stated that both biosimilars will have a 15% lower wholesale acquisition cost (WAC) than their reference treatments.  The companies added that at launch, Mvasi® will be priced 12% below Avastin®’s current average selling price, with Kanjinti® carrying a 13% lower average selling price versus Herceptin®.
Mvasi® became the first cancer biosimilar in the US with its approval for multiple cancer types in 2017. Kanjinti® was authorized by the FDA in June for breast and gastric cancer, marking it the fifth approved biosimilar referencing Herceptin®.
Read more about the launches here. 
 

ASBM Poster Abstract Accepted at ESMO Congress 2019

On July 18th, ASBM was notified by the European Society of Medical Oncology (ESMO) that its poster abstract submission was accepted for the ESMO Congress 2019, to be held in Barcelona, Spain from September 27th to October 1st.
ASBM’s abstract is entitled “Biosimilar Substitution: European Prescriber Perspectives”, and will examine in detail the perspectives of European physicians on several biosimilar policy issues including prescription autonomy, non-medical switching, tendering practices, and product identification. A key focus will be on the perspectives of oncologists.
Data will be drawn from a 2019 ASBM survey of 575 European prescribers of biologic medicines from a variety of specialties, which will be released this fall.
Read more about ESMO Congress 2019 here. 
 

ASBM Joins Patient Advocacy Groups in Opposing Shared CMS Billing Codes for Multiple Biologic Products

On July 16th, A group of patient advocacy organizations sent a letter to Sen Finance Committee members Ron Wyden (D-OR) and Chuck Grassley (R-IA), opposing any changes to CMS policy that would result in the use of shared billing codes to cover multiple different products. The letter was organized by ASBM member Alliance for Patient Access (AfPA) and the Biologic Prescribers’ Collective (BPC), a project of AfPA.
ASBM and AfPA were among the many patient advocacy organizations that opposed the use of shared billing codes by CMS. Read ASBM’s September 2017 comment letter to CMS opposing the shared billing code policy here. 

In November 2017, CMS announced the reversal of the policy, following a public comment period which found strong opposition among patient advocacy organizations, physician societies, and manufacturers of both originator biologics and biosimilars. It has been estimated that the adoption of unique billing codes will save $65 billion to Medicare over ten years.

In an Inside Health Policy article published June 29th, Sen. Wyden had proposed returning to the policy of shared codes.
ASBM Exhibits, Presents at DIA 2019 Global Annual Meeting
From June 24th to June 26th, ASBM exhibited at the DIA 2019 Global Annual Meeting in San Diego, CA. The meeting hosted thousands of professionals in the pharmaceutical, biotechnology, and medical device communities from more than 50 countries around the globe and 400+ exhibiting companies.

 

ASBM was represented at DIA 2019 by Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, both of whom met with conference attendees to discuss ASBM’s work. Among the booth’s visitors was WHO INN Programme Lead Dr. Raffaella Balocco, who was a speaker at a panel on global pharmacovigilance.

 

Literature was distributed at ASBM’s booth on key biosimilar policy issues including: biosimilar basics, distinct naming, substitution and interchangeability, product labeling, indication extrapolation, and international harmonization of biologic nomenclature.

 

On Thursday, June 27th, Dr. Schneider participated in a session entitled “Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars“. In his presentation, Schneider discussed the importance of redundancy in high reliability systems, with respect to clear product identification and biologic naming. Schneider noted that in Europe, where multiple biosimilars share a nonproprietary name with the originator biologic upon which they are based, roughly a third of adverse event reports for infliximab products do not identify the specific product responsible by its brand name.

 

View Dr. Schneider’s presentation here. 

 

Read more about the ASBM’s DIA exhibit and presentation here. 

 
ASBM’s Michael Reilly Published in Vancouver Sun

 

On June 24th, the Vancouver Sun published an op-ed by ASBM Executive Director Michael Reilly expressing concern about a recently-announced British Columbia mandated-switching policy. The policy, announced May 27th, will forcibly switch 23,000 patients to biosimilars in the coming months.

 

The op-ed points out that the proposed forced switch policy in BC misconstrues the European experience with biosimilars which has primarily left medical decisions in the hands of the treating physicians. From the op-ed:

 

Biosimilars have increased competition, expanded the choice of products physicians can choose from, increased the number of patients with access to these highly effective biologics, and provided headroom to fund innovative drugs.

 

However, it is important to note that in the vast majority of European countries, the decision of what medicine to choose has remained with the treating physician in consultation with their patient — contrary to the government mandated forced switch of well-treated patients announced by [BC Health Minister Adrian] Dix.

 

Furthermore, Health Canada, like the European Medicines Agency, recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.

 

Read the full op-ed here. 

 

Read ASBM’s Fact Sheet covering the differences between BC and EU substitution policies here.
ASBM Exhibits at 2019 BIO International Conference

 

From June 4th-6th, ASBM exhibited at the 2019 BIO International Convention held in Philadelphia, PA. Each year, the Convention attracts approximately 16,000 attendees from more than 5,000 companies and from 70 different countries.

 

ASBM was represented at the booth by Andrew Spiegel, ASBM Steering Committee member and executive director of the Global Colon Cancer Association. Conference attendees met with Mr. Spiegel and discussed key biosimilar policy issues including biosimilar naming and non-medial switching policy.

 

While at the BIO Convention, Mr. Spiegel also participated in a panel discussion with other patient advocates and biologic manufacturers to discuss the importance to patients of building a sustainable biosimilar market.

 

Read more about the 2019 Bio Convention here. 

 
 
FDA Approves Two New Biosimilars in June

 

During the month of June, the FDA approved two new biosimilars, bringing the total approved to 21.

 

The first product, ZIRABEV® (bevacizumab-bvzr) is biosimilar to AVASTIN® (bevacizumab). Like its reference product, it is a vascular endothelial growth factor inhibitor indicated for the treatment of metastatic colorectal cancer. It is the second bevacizumab biosimilar approved by the FDA.

 

The second product, KANJINTI® (trastuzumab-anns) is biosimilar to HERCEPTIN® (trastuzumab). Like its reference product, it is a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fifth trastuzumab biosimilar approved by the FDA.

 

 
UPCOMING EVENTS

 

ESMO Congress 2019

Barcelona, Spain – September 27-October 1

 

World Biosimilar Congress 2019 – Europe 

Basel, Switzerland – October 15-16

 

WHO 69th INN Consultation

Geneva, Switzerland – October 22

 

DIA Annual Canadian Meeting

Gatineau, Quebec – November 5-6
 

 

June-July 2019 Newsletter

August 1, 2019

newsletter | June-July 2019
issue 79
 
 
 

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.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
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ASBM Statement on Prescription Drug Price Reduction Act (PDPRA)

 

On July 25th, the U.S. Senate Committee on Finance passed the Prescription Drug Pricing Reduction Act (PDPRA) of 2019, in a vote of 19-9. On July 29th, ASBM released a statement outlining concerns with one of the bill’s provisions. From the statement:

 

The stated aims of the bill include lowering prescription drug prices and boosting biosimilar uptake; these goals are shared by ASBM and many others in the physician and patient advocacy community. One provision in the PDPRA, however, raises serious concerns.

 

According to the bill, higher reimbursement rates will be paid to physicians who prescribe biosimilar biologic products under Medicare Part B than originator biologic products. If implemented, this plan to provide the doctor a 33% bonus for use of a biosimilar would insert financial incentives where patient interests should prevail. Every patient should be confident that their physician will prescribe the product that is in their best interest…not the one that is the most profitable to the physician personally. This proposed scheme fundamentally undermines the patient-physician relationship of trust.

 

ASBM’s position has been and continues to be that treatment decisions should be based on what is best for the patient, unfettered by third-party influence. That decision should take into consideration a number of factors, including the affordability of the drug for the patient, not profit for the physician.

 

 

Read the full statement here. 
Two New Biosimilars Available in US in July

On July 19th, biologics manufacturers Amgen and Allergan announced that the biosimilars Mvasi® (bevacizumab-awwb) and Kanjinti® (trastuzumab-anns), which reference Roche cancer drugs Avastin® (bevacizumab) and Herceptin® (trastuzumab), respectively, are now available in the US.
“As the first products from our collaboration with Amgen to be launched in the country, Mvasi® and Kanjinti® reinforce our ongoing dedication to providing patients with additional treatment options,” said David Nicholson, chief R&D officer at Allergan.
The drugmakers stated that both biosimilars will have a 15% lower wholesale acquisition cost (WAC) than their reference treatments.  The companies added that at launch, Mvasi® will be priced 12% below Avastin®’s current average selling price, with Kanjinti® carrying a 13% lower average selling price versus Herceptin®.
Mvasi® became the first cancer biosimilar in the US with its approval for multiple cancer types in 2017. Kanjinti® was authorized by the FDA in June for breast and gastric cancer, marking it the fifth approved biosimilar referencing Herceptin®.
Read more about the launches here. 
 

ASBM Poster Abstract Accepted at ESMO Congress 2019

On July 18th, ASBM was notified by the European Society of Medical Oncology (ESMO) that its poster abstract submission was accepted for the ESMO Congress 2019, to be held in Barcelona, Spain from September 27th to October 1st.
ASBM’s abstract is entitled “Biosimilar Substitution: European Prescriber Perspectives”, and will examine in detail the perspectives of European physicians on several biosimilar policy issues including prescription autonomy, non-medical switching, tendering practices, and product identification. A key focus will be on the perspectives of oncologists.
Data will be drawn from a 2019 ASBM survey of 575 European prescribers of biologic medicines from a variety of specialties, which will be released this fall.
Read more about ESMO Congress 2019 here. 
 

ASBM Joins Patient Advocacy Groups in Opposing Shared CMS Billing Codes for Multiple Biologic Products

On July 16th, A group of patient advocacy organizations sent a letter to Sen Finance Committee members Ron Wyden (D-OR) and Chuck Grassley (R-IA), opposing any changes to CMS policy that would result in the use of shared billing codes to cover multiple different products. The letter was organized by ASBM member Alliance for Patient Access (AfPA) and the Biologic Prescribers’ Collective (BPC), a project of AfPA.
ASBM and AfPA were among the many patient advocacy organizations that opposed the use of shared billing codes by CMS. Read ASBM’s September 2017 comment letter to CMS opposing the shared billing code policy here. 

In November 2017, CMS announced the reversal of the policy, following a public comment period which found strong opposition among patient advocacy organizations, physician societies, and manufacturers of both originator biologics and biosimilars. It has been estimated that the adoption of unique billing codes will save $65 billion to Medicare over ten years.

In an Inside Health Policy article published June 29th, Sen. Wyden had proposed returning to the policy of shared codes.
ASBM Exhibits, Presents at DIA 2019 Global Annual Meeting
From June 24th to June 26th, ASBM exhibited at the DIA 2019 Global Annual Meeting in San Diego, CA. The meeting hosted thousands of professionals in the pharmaceutical, biotechnology, and medical device communities from more than 50 countries around the globe and 400+ exhibiting companies.

 

ASBM was represented at DIA 2019 by Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, both of whom met with conference attendees to discuss ASBM’s work. Among the booth’s visitors was WHO INN Programme Lead Dr. Raffaella Balocco, who was a speaker at a panel on global pharmacovigilance.

 

Literature was distributed at ASBM’s booth on key biosimilar policy issues including: biosimilar basics, distinct naming, substitution and interchangeability, product labeling, indication extrapolation, and international harmonization of biologic nomenclature.

 

On Thursday, June 27th, Dr. Schneider participated in a session entitled “Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars“. In his presentation, Schneider discussed the importance of redundancy in high reliability systems, with respect to clear product identification and biologic naming. Schneider noted that in Europe, where multiple biosimilars share a nonproprietary name with the originator biologic upon which they are based, roughly a third of adverse event reports for infliximab products do not identify the specific product responsible by its brand name.

 

View Dr. Schneider’s presentation here. 

 

Read more about the ASBM’s DIA exhibit and presentation here. 

 
ASBM’s Michael Reilly Published in Vancouver Sun

 

On June 24th, the Vancouver Sun published an op-ed by ASBM Executive Director Michael Reilly expressing concern about a recently-announced British Columbia mandated-switching policy. The policy, announced May 27th, will forcibly switch 23,000 patients to biosimilars in the coming months.

 

The op-ed points out that the proposed forced switch policy in BC misconstrues the European experience with biosimilars which has primarily left medical decisions in the hands of the treating physicians. From the op-ed:

 

Biosimilars have increased competition, expanded the choice of products physicians can choose from, increased the number of patients with access to these highly effective biologics, and provided headroom to fund innovative drugs.

 

However, it is important to note that in the vast majority of European countries, the decision of what medicine to choose has remained with the treating physician in consultation with their patient — contrary to the government mandated forced switch of well-treated patients announced by [BC Health Minister Adrian] Dix.

 

Furthermore, Health Canada, like the European Medicines Agency, recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.

 

Read the full op-ed here. 

 

Read ASBM’s Fact Sheet covering the differences between BC and EU substitution policies here.
ASBM Exhibits at 2019 BIO International Conference

 

From June 4th-6th, ASBM exhibited at the 2019 BIO International Convention held in Philadelphia, PA. Each year, the Convention attracts approximately 16,000 attendees from more than 5,000 companies and from 70 different countries.

 

ASBM was represented at the booth by Andrew Spiegel, ASBM Steering Committee member and executive director of the Global Colon Cancer Association. Conference attendees met with Mr. Spiegel and discussed key biosimilar policy issues including biosimilar naming and non-medial switching policy.

 

While at the BIO Convention, Mr. Spiegel also participated in a panel discussion with other patient advocates and biologic manufacturers to discuss the importance to patients of building a sustainable biosimilar market.

 

Read more about the 2019 Bio Convention here. 

 
 
FDA Approves Two New Biosimilars in June

 

During the month of June, the FDA approved two new biosimilars, bringing the total approved to 21.

 

The first product, ZIRABEV® (bevacizumab-bvzr) is biosimilar to AVASTIN® (bevacizumab). Like its reference product, it is a vascular endothelial growth factor inhibitor indicated for the treatment of metastatic colorectal cancer. It is the second bevacizumab biosimilar approved by the FDA.

 

The second product, KANJINTI® (trastuzumab-anns) is biosimilar to HERCEPTIN® (trastuzumab). Like its reference product, it is a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fifth trastuzumab biosimilar approved by the FDA.

 

 
UPCOMING EVENTS

 

ESMO Congress 2019

Barcelona, Spain – September 27-October 1

 

World Biosimilar Congress 2019 – Europe 

Basel, Switzerland – October 15-16

 

WHO 69th INN Consultation

Geneva, Switzerland – October 22

 

DIA Annual Canadian Meeting

Gatineau, Quebec – November 5-6
 

 

ASBM Exhibits, Presents at DIA 2019 Annual Meeting

July 29, 2019

dia2019-balocco-small
WHO INN Programme Lead Dr. Raffaella Balocco visits with Advisory Board Chair Philip Schneider (left) and Executive Director Michael Reilly (right) at ASBM’s booth.

From June 24th to June 26th, ASBM exhibited at the DIA 2019 Global Annual Meeting in San Diego, CA. ASBM was represented by Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, who met with conference attendees to discuss ASBM’s work.

ASBM distributed literature on key biosimilar policy issues including: biosimilar basics, distinct naming, substitution and interchangeability, product labeling, indication extrapolation, and international harmonization of biologic nomenclature. Among the booth’s visitors was WHO INN Programme Lead Dr. Raffaella Balocco, who was a speaker at a DIA panel on pharmacovigilance.

tabletop

On Thursday, June 27th, Dr. Schneider participated in a session entitled “Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars“. In his presentation, Schneider discussed the importance of redundancy in high reliability systems, with respect to clear product identification and biologic naming. Schneider noted that in Europe, where multiple biosimilars share a nonproprietary name with the originator biologic upon which they are based, roughly a third of adverse event reports for infliximab products do not identify the specific product responsible by its brand name.

diapanel-aereports

A system of distinct nonproprietary naming (such a the suffix systems proposed by WHO and enacted by FDA) would add an additional safeguard and minimize the risks of such pharmacovigilance problems, Schneider explained. View Dr. Schneider’s presentation here. 

diapanel

Other presenters in the session included Kalindi Hapani, MPharm of APCER Life Sciences; Brian Edwards, DrMed, of ACRES, NDA Group;  and Lubna Merchant, PharmD, MS, of FDA.

 

 

 

 

ASBM Joins Patient Advocacy Groups in Opposing Shared CMS Billing Codes for Multiple Biologic Products

July 16, 2019

On July 16th, A group of patient advocacy organizations sent a letter to Senate Committee on Finance members Ron Wyden (D-OR) and Chuck Grassley (R-IA), opposing any changes to CMS policy that would result in the use of shared billing codes to cover multiple different products. The letter was organized by ASBM member Alliance for Patient Access (AfPA) and the Biologic Prescribers’ Collective (BPC), a project of AfPA.

ASBM and AfPA were among the many patient advocacy organizations that opposed the use of shared billing codes by CMS. Read ASBM’s September 2017 comment letter to CMS opposing the shared billing code policy here. 


In November 2017, CMS announced the reversal of the policy, following a public comment period which found strong opposition among patient advocacy organizations, physician societies, and manufacturers of both originator biologics and biosimilars. It has been estimated that the adoption of unique billing codes will save $65 billion to Medicare over ten years.

In an Inside Health Policy article published June 29th, Sen. Wyden had proposed returning to the policy of shared codes.

Read the full letter here. 

ASBM Op-ed published in Vancouver Sun

June 24, 2019

Michael Reilly: Forcing patients to switch to biosimilars puts them in uncharted waters

MICHAEL REILLY
Updated: June 24, 2019

On May 27, the B.C. government announced a policy that will forcibly switch thousands of patients, effective Nov. 22, with serious, chronic conditions from their current biologic medicines to lower-cost “biosimilar” treatments.

The roughly 23,000 patients who will be affected include those with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, diabetes, Crohn’s Disease and ulcerative colitis.

Such switches are widely accepted with generic versions of small-molecule drugs, which are identical copies of the originator medicine. But biosimilars, while highly similar to their reference products, are not identical.

In making this decision, Health Minister Adrian Dix correctly observed the comparatively higher uptake of, and savings from, biosimilars in Europe. Europe and the European Medicines Agency have been the leaders in the development of a regulatory framework for biosimilars since the early 2000s, with the first biosimilar approved in 2006 and a total of 60 approved biosimilar products/brands covering 17 originator molecules to date.

But biosimilar market shares across Europe vary widely between 41 per cent and 91 per cent for those approved before 2012, and between five per cent and 43 per cent for those approved between 2013 and 2018. As with innovative biologic medicines, their uptake has evolved over time as both physicians and patients gradually gained experience with this new class of medicines.

Biosimilars have increased competition, expanded the choice of products physicians can choose from, increased the number of patients with access to these highly effective biologics, and provided headroom to fund innovative drugs.

However, it is important to note that in the vast majority of European countries, the decision of what medicine to choose has remained with the treating physician in consultation with their patient — contrary to the government mandated forced switch of well-treated patients announced by Dix.

Like the European Medicines Agency, Health Canada states that, one, biosimilars are not considered generics, two, that the authorization of a biosimilar is not a declaration of equivalence to the original biologic drug and, three, that the authority to declare two products interchangeable rests with each province and territory.

Furthermore, Health Canada, European Medicines Agency, recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.

With the above in mind, it is important to differentiate between two types of patients:

First are those about to begin treatment on a biologic, for which a biosimilar is available — referred to as “bio-naïve” patients.

Second are patients who have been fortunate to see their disease controlled or even reversed, possibly for years, with an original biologic. This latter group has often tried multiple different products before finding the one that has stabilized their condition.

For the new patient, a choice between the original biologic and a biosimilar would be the choice between two equals, given the patient’s non-exposure to either medicine in the past.

Yet for the second group — the patients who are stable on their current medicine — switching a well-treated patient from their familiar and effective original biologic to a biosimilar is a thoroughly different decision. It’s even more so if such a decision is mandated for all patients and not left at the discretion of the treating physician who alone is able to make such a judgment call, weighing all the pros (cost) and cons — change of syringe/pen, patient compliance, adverse events, immunogenic reactions, possible change to a different drug altogether, etc. — plus the time and resources required by physicians and their staff to provide the necessary information to each patient.

Despite the first biosimilar approval in Europe in 2006, the number of approved biosimilars, even in Europe, is still relatively small. The vast majority of EU countries have treaded carefully as their policies have evolved, seeking procurement solutions that would promote competition, maintain product choice and preserve physician autonomy.

Over time, prices have come down and, as physicians have gained experience, more patients have been treated, even though at varying degrees depending on the type of biologic/biosimilar. That reflects both the level of competition but even more so the differences in disease complexities, patient types and resulting considerations for successful treatment outcomes.

The vast majority of European countries do not serve as a reference for a forced-switch biosimilar policy like the one introduced in B.C. Biosimilar uptake in Europe has mostly been a result of building physician trust and confidence, rather than force. Instead, the European success with biosimilars stems from extensive stakeholder education, frequent communication, refined procurement policies and a recognition that only a long-term, sustainable biosimilar market will secure the continued development of new biosimilars and their adoption by both physicians and their patients.

Michael Reilly is executive director of the Alliance for Safe Biologic Medicines, an organization composed of healthcare groups and individuals, including patients, physicians and biotechnology companies, that develop innovative and biosimilar medicines and others working to ensure patient safety is at the forefront of biosimilars policy discussions.

 

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