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.

 

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.

 

ASBM Exhibits at 2019 BIO Conference

June 8, 2019

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

andy-bio2019

ASBM was represented at the booth by Andrew Spiegel, ASBM Steering Committee member and executive director of the Global Colon Cancer Association. At ASBM’s booth, attendees met with Mr. Spiegel and discussed key biosimilar policy issues including biosimilar naming and non-medial switching policy. ASBM’s booth offered a variety of literature on these and other topics including the biosimilar approval process, indication extrapolation, product labeling, and the results of recent physician surveys regarding their biosimilar policy preferences.

andy-bio-panel

While at the BIO Convention, 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. 

ASBM Exhibits at 2019 BIO Conference

June 8, 2019

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

andy-bio2019

ASBM was represented at the booth by Andrew Spiegel, ASBM Steering Committee member and executive director of the Global Colon Cancer Association. At ASBM’s booth, attendees met with Mr. Spiegel and discussed key biosimilar policy issues including biosimilar naming and non-medial switching policy. ASBM’s booth offered a variety of literature on these and other topics including the biosimilar approval process, indication extrapolation, product labeling, and the results of recent physician surveys regarding their biosimilar policy preferences.

andy-bio-panel

While at the BIO Convention, 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. 

Patients, Physicians Raise Concerns with BC Biosimilar Non-Medical Switching Policy

June 6, 2019

ARLINGTON, Va., June 6, 2019 /PRNewswire/ — On May 27th, the Government of British Columbia (B.C.) announced a policy that will forcibly switch thousands of patients with serious, chronic conditions from their current biologic medicines to lower-cost “biosimilar” treatments, effective November 25th, 2019. 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. The announcement raises concerns among patients and physicians, according to the Alliance for Safe Biologic Medicines (ASBM), an international organization of patient advocates, physicians, and manufacturers of both biosimilars and originator products. ASBM, which has 16 Canadian members, is a member of the Canadian Biosimilars Working Group, has hosted and participated in a series of meetings with Health Canada and provincial health ministries on the topic of biosimilars and in 2017 conducted a survey of 403 Canadian prescribers of biologics.

Biosimilars are highly similar to the original biologic medicines but not identical, therefore they have not been considered “generic” drugs or appropriate for substitution for the original product without involvement of the prescribing health care provider.

Governments looking to control health costs and improve access to biologic therapies may turn to biosimilars as a tool. However, the announcement in B.C. is an example of “non-medical switching”- switching that results from or is driven by policy changes rather than the patient’s best medical interest. The controversial practice is often euphemistically referred to as a “transition” by proponents. While biosimilars are safe and effective products in their own right, no studies are required to demonstrate the safety and efficacy impacts of switching patients between originator and biosimilar. Canadian physicians have expressed serious concerns with third parties forcing non-medical biosimilar switching of patients who are stable and well-treated on their current medicine, effectively removing patient care from the physician’s authority.

According to the 2017 Canadian prescriber survey:

  • 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;
  • 79% considered it “very important” or “critical” to have the authority to designate on a prescription for a biologic medicine “Dispense as Written” or “Do Not Substitute”;
  • 82% of physicians support switching studies before a third party may automatically substitute a biologic.

Health Canada recommends that a decision to switch a patient 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.”

“Governments looking to expand access and trim health costs, such as B.C.’s, should view the legitimate concerns of health-care professionals and patients as an opportunity to provide education and increase choice and competition, as has been the successful approach in other countries,” said Michael Reilly, executive director of ASBM.

The B.C. government took this opportunity to announce it would begin to cover two new biologic medicines, both already covered in neighboring provinces. “Providing access to new biologic medicines is commendable and appropriate but linking access to the forced switching of patients and limiting physician choice is not acceptable,” Reilly added.  “As many countries have shown, there are other ways to put patients first and realize savings without restricting medication choice. In Europe, for example, the vast majority of countries do not force well-treated patients to switch biologics, yet they have a robust and evolving biosimilar market. In light of physician, pharmacist and patient concerns, in the absence of any medical benefit, and with other ways to control costs, we join patients, physicians and pharmacists in opposing this approach and urging reconsideration.”

Contact: media@safebiologics.org

Patients, Physicians Raise Concerns with BC Biosimilar Non-Medical Switching Policy

June 6, 2019

ARLINGTON, Va., June 6, 2019 /PRNewswire/ — On May 27th, the Government of British Columbia (B.C.) announced a policy that will forcibly switch thousands of patients with serious, chronic conditions from their current biologic medicines to lower-cost “biosimilar” treatments, effective November 25th, 2019. 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. The announcement raises concerns among patients and physicians, according to the Alliance for Safe Biologic Medicines (ASBM), an international organization of patient advocates, physicians, and manufacturers of both biosimilars and originator products. ASBM, which has 16 Canadian members, is a member of the Canadian Biosimilars Working Group, has hosted and participated in a series of meetings with Health Canada and provincial health ministries on the topic of biosimilars and in 2017 conducted a survey of 403 Canadian prescribers of biologics.

Biosimilars are highly similar to the original biologic medicines but not identical, therefore they have not been considered “generic” drugs or appropriate for substitution for the original product without involvement of the prescribing health care provider.

Governments looking to control health costs and improve access to biologic therapies may turn to biosimilars as a tool. However, the announcement in B.C. is an example of “non-medical switching”- switching that results from or is driven by policy changes rather than the patient’s best medical interest. The controversial practice is often euphemistically referred to as a “transition” by proponents. While biosimilars are safe and effective products in their own right, no studies are required to demonstrate the safety and efficacy impacts of switching patients between originator and biosimilar. Canadian physicians have expressed serious concerns with third parties forcing non-medical biosimilar switching of patients who are stable and well-treated on their current medicine, effectively removing patient care from the physician’s authority.

According to the 2017 Canadian prescriber survey:

  • 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;
  • 79% considered it “very important” or “critical” to have the authority to designate on a prescription for a biologic medicine “Dispense as Written” or “Do Not Substitute”;
  • 82% of physicians support switching studies before a third party may automatically substitute a biologic.

Health Canada recommends that a decision to switch a patient 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.”

“Governments looking to expand access and trim health costs, such as B.C.’s, should view the legitimate concerns of health-care professionals and patients as an opportunity to provide education and increase choice and competition, as has been the successful approach in other countries,” said Michael Reilly, executive director of ASBM.

The B.C. government took this opportunity to announce it would begin to cover two new biologic medicines, both already covered in neighboring provinces. “Providing access to new biologic medicines is commendable and appropriate but linking access to the forced switching of patients and limiting physician choice is not acceptable,” Reilly added.  “As many countries have shown, there are other ways to put patients first and realize savings without restricting medication choice. In Europe, for example, the vast majority of countries do not force well-treated patients to switch biologics, yet they have a robust and evolving biosimilar market. In light of physician, pharmacist and patient concerns, in the absence of any medical benefit, and with other ways to control costs, we join patients, physicians and pharmacists in opposing this approach and urging reconsideration.”

Contact: media@safebiologics.org

ASBM Exhibits at DDW 2019

June 5, 2019

From May 19-21, 2019 ASBM exhibited at the DDW 2019 Conference held in San Diego, CA. DDW is the one of the largest gatherings of gastroenterologists in the world, boasting more than 14,000 attendees. The conference is hosted by the American Gastroenterological Association (AGA), an ASBM member. 2019 marks the conference’s fiftieth year.

ASBM exhibited in the Community Corner, reserved for non-profits and patient advocacy organizations. ASBM staff met with gastroenterologists from around the world, and discussed key biosimilar policy issues including naming, substitution policy, and interchangeability. ASBM’s booth also made one pagers available on these and other biosimilar issues.

ddwbooth

Several ASBM members also exhibited, including the Global Colon Cancer Association (GCCA), the Colorectal Cancer Alliance (CCA), and Fight Colorectal Cancer (Fight CRC).

May 2019 Newsletter

June 1, 2019

newsletter | May 2019
issue 78

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: michael@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 971 – 1700
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ASBM Presents on Naming at World Biosimilar Congress USA 2018

 

On May 24th, ASBM presented at the World Biosimilars Congress USA 2018 in San Diego, CA. The theme of the two-day conference was “Helping the global industry bring biosimilars to the US” and it drew more than 100 attendees including representatives from the industry, health care professionals, and payers.

 

ASBM Advisory Chair Philip Schneider gave a presentation entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals worldwide regarding the need for all biologics, including biosimilars to have distinct non-proprietary names.

 

Dr. Schneider discussed the feasibility of four-letter suffixes -as proposed by the World Health Organization (WHO) and enacted by the U.S. Food and Drug Administration (FDA)- in addressing this need. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC and his April 30th meeting with WHO in Geneva, emphasizing the importance of the WHO assuming a leadership role on this issue:

 

“International harmonization is key to building a strong global system of pharmacovigilance, and countries without robust pharmacovigilance systems in place may benefit the most from distinct naming and international harmonization. WHO leadership is essential to achieve this and avoid further proliferation of country-specific naming schemes.”

 

View Dr. Schneider’s presentation here. 

 

 
ASBM Meets with Patient Groups Worldwide at IAPO Conference

 

On May 23rd-24th, ASBM attended the International Alliance of Patients’ Organizations 8th Global Patients Congress.

 

The meeting was attended by approximately 80 different patient groups and 130 participants from around the globe which convene on a number of health topics—including sessions on how best to engage regulators worldwide and a 101 on biosimilar medicines. ASBM also hosted a booth which highlighted the importance of the harmonization of naming schemes for biologics and biosimilars and included a poster presentation of results from physicians in 12 countries surveyed by ASBM.  View the poster here.

 

At the meeting ASBM Steering Committee member and Global Colon Cancer Association Executive Director, Andrew Spiegel, was named as the Chair-elect to be IAPO Chairman in August of 2020.

 

“We send ASBM’s congratulations to Andy for his recognition as a top notch global patient advocate and look forward to his leadership at IAPO,” stated Dr. Madelaine Feldman, ASBM Chair. 

 

ASBM Welcomes New Member Esperantra

 

At the 2018 IAPO meeting, ASBM engaged with many patient organizations and as a result would like to welcome Esperantra to ASBM membership.

 

Esperantra is a non-profit organization created for the purpose of contributing to the reduction of cancer mortality in Peru by improving the quality of life of cancer patients, and advocating for equality in access to quality treatments and to innovative care.  Esperantra is the first organization of its kind to provide information and support, and to advocate on behalf of cancer patients through its different programs.  Their mission is to inform, educate and empower people to achieve a timely diagnosis through prevention programs and to access treatments to control the disease.

 

Through the meeting of Director Karla Ruiz De Castilla Yabar, ASBM learned that Esperantra has been following regulations in their country on biologic medicines and been active in giving lectures on the issue.

 

We welcome Esperantra to ASBM’s membership—especially as we tackle such global issues as the naming of biologics and biosimilars,” stated ASBM Executive Director, Michael Reilly.  “All patients, no matter what continent they live, should be able to benefit from knowing that their medicines are safe and effective. The harmonization of biologic naming will benefit all patients, no matter where they are being treated.”

 

Learn more about Esperantra here. 

 

 
ASBM Presents at World Health Professions Regulation Conference

 

On May 17th, ASBM presented an abstract during the poster session at the World Health Professions Regulation Conference 2018 in Geneva, Switzerland.

 

ASBM’s poster, entitled “How do policymakers realize the cost-savings from biosimilars while maintaining healthcare provider autonomy?” draws from ASBM’s surveys of 1,832 physicians in 12 countries and 401 pharmacists in the U.S.

 

The findings were presented by ASBM’s International Advisory Board Chair, Philip J. Schneider, MS, FASHP, FASPEN, FFIP; who co-authored the abstract with ASBM Executive Director, Michael Reilly, Esq.

 

The conference, in its fifth year, is sponsored by the World Health Professions Alliance, an international organization representing dentists, nurses, pharmacists, physicians, and physical therapists.

 

Read more about WHPRC 2018 here. 

 

View the poster here. 

 
FDA Approves Tenth Biosimilar

 

On May 15th, the U.S. Food and Drug Administration approved its tenth biosimilar, Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

 

“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

 

The FDA’s approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. Retacrit has been approved as a biosimilar, not as an interchangeable product.

 

Read more about the FDA’s approval here. 

 
ASBM Chair Testifies in Support of Bill Forbidding Mid-Year Formulary Changes for Stable Patients

 

On May 10th, ASBM Chair Madelaine Feldman testified in support of Illinois House Bill 4146, which essentially forbids mid-year formulary change on a patient who is stable on their medicine. Other proponents included the Coalition of State Rheumatology Organizations, an ASBM member, and patient advocacy groups including the Arthritis Foundation.

 

The bill passed the Senate on May 25th and has been placed on the House Calendar of Order for Concurrence with Senate Amendments.
Read more about HB 4146 here. 

 

 
U.S. State Substitution Update
Currently, 43 states and Puerto Rico have now enacted laws permitting the substitution of an interchangeable biosimilar in place of a prescribed biologic. Two additional bills sit on the desks of the Governors of Alaska and Connecticut awaiting signature. Each state’s law provides that the pharmacist should communicate to the prescribing physician in a timely manner which product was dispensed — the originator or the biologic. Physicians also retain the ability to prevent a substitution they deem medically inappropriate for their patient. States with recent activity include: 

Connecticut: On May 22nd, the House transmitted S 197 to Governor Dannel Malloy for signature.

 

New Hampshire: On May 3rd, HB 1791 was passed by the Senate and sent to Governor Chris Sununu for signature.  On June 7th, there was a signing ceremony by Governor Sununu.   Read ASBM’s letter urging Governor Sununu to sign HB 1791 here. 

 

Vermont: On May 30th, Governor Phil Scott signed S 92, making Vermont the 42nd state to enact biosimilar substitution legislation.

 

 
UPCOMING ASBM EVENTS

 

DIA Annual Conference

Boston, MA – June 24-28

 

International Pharmaceutical Federation Meeting

Glasgow, Scotland – September 1

 

Rhode Island Health Systems Pharmacists CE Course

Providence, RI – September 26

 

Long Island University College of Pharmacy CE Course

Queens, NY – September 30

 

Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products

May 14, 2019

Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products

May 13, 2019

 

Arlington, VA – US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.

 

Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7th.

 

Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School. Alliance for Safe Biologic Medicines (ASBM) was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.

 

In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”. Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology, nephrology, and ophthalmology. The full survey may be viewed here.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.

 

“US physicians have once again spoken very clearly in support of the FDA and of distinct naming”, said Madelaine Feldman, MD FACR, Chairwoman of ASBM, who conducted the survey.

 

A minority of parties submitting comments to the FDA during the recent comment period opposed the FDA policy, including health insurance companies, national chain drug stores, and pharmacy benefit managers. Opponents of distinct naming submitted 17 individual comment letters and a joint comment letter with 29 signatories, compared to more than 250 organizations and individuals who wrote in directly or signed letters of support. Still other commenters supported distinct naming, but had comments on the suffix design or implementation. Biologic manufacturers varied widely in their support.

 

“Biosimilars offer patients increased access to life-changing therapies, at reduced cost for patients and our health system. In order to reap these benefits, physicians and patients need confidence that adverse events will be attributed to the correct product, be it originator or biosimilar. Physicians and patients have spoken clearly to FDA: distinct naming is essential to building that confidence”, said Dr. Feldman.

 

###

About the Alliance for Safe Biologic Medicines

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups including physicians, patients, pharmacists, manufacturers of innovator biologics and biosimilars, researchers, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

Media contact: Ray Patnaude media@safebiologics.org

April 2019 Newsletter

May 1, 2019

newsletter | April 2019
issue 77
 
 
 

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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Physicians, Patients Express Overwhelming Support for FDA Distinct Biologic Naming Plan
US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.

 

Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7th.

 

Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School.

ASBM was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.
In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.
Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology,
nephrology, and ophthalmology.

Read ASBM’s press release and about the comments and survey here. 

The full survey may be viewed here.

 

 
FDA Finalizes Interchangeability Guidance
This month, the FDA finalized its guidance on the pathway for interchangeable biologics, which may be substituted without the involvement of the prescriber. From a statement by Acting FDA Commissioner Norman E. Sharpless, MD:
Today’s final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product. Once an application or supplement seeking licensure as an interchangeable product is submitted, the FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement is sufficient to meet the applicable statutory standard: among other things, that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient. The guidance also explains potential ways to address the BPCI Act requirement for interchangeability that, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product will not be greater than the risk of using the reference product without such alternation or switch.

 

Read the full FDA Statement here and the Final Guidance here. 
FDA Approves 19th Biosimilar, Second for Etanercept

 

In late April, FDA approved Eticovo (etanercept-ykro), the second biosimilar for etanercept.

 

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Eticovo has been approved across all eligible indications, namely ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and rheumatoid arthritis.

Read more about the FDA approval here.

 
ASBM Presents at 68th WHO INN Consultation

 

On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth INN Consultation at which ASBM has presented since 2013.

 

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 67th INN Consultation may be viewed here.

 

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

 

In the past year, ASBM has held three meetings to discuss international harmonization of biologic nomenclature. Participants included representatives from the FDA, Health Canada, the WHO, physician and pharmacist societies, and patient advocacy organizations. The first two meetings took place in April and July 2018 in Washington, DC, and the third in March 2019 in Ottawa, Ontario. A white paper on the first of these meetings may be read here. 

 

 
UPCOMING ASBM EVENTS

 

Digestive Disease Week

San Diego, CA – May 18-21

 

BIO International Convention

Philadelphia, PA – June 3-5

 

DIA Annual Meeting

San Diego, CA – June 23-27
 

 
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