Who We Are
The Alliance for Safe Biologic Medicines is an organization 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 the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Our Perspective
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
| ASBM Letter to Congress: Paying Physicians to Prescribe Government-Preferred Biosimilars Undermines Patient-Physician Relationship
On December 2nd, ASBM sent a letter to House leaders reiterating our opposition to a proposal that would undermine the patient-physician relationship and distort the making of treatment decisions. The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar.
The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” that would increase the reimbursement to physicians from 6% above average sale price (ASP) to 8%- if they prescribe the biosimilar.
Biosimilars have already achieved significant US market share, around 80% for filgrastim biosimilars, 70% for trastuzumab and bevacizumab biosimilars, and 55% for rituximab biosimilars. As more become available, the increased competition has driven down prices of both biosimilars and innovator biologics.
Despite these successes, supporters of artificially incentivizing biosimilar uptake have continued to insert this provision into several bills in recent years. From the letter:
Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. 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.
We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies.
We also firmly believe this proposal is unnecessary, misguided, and potentially harmful. Instead, all products should continue to compete on a level playing field. Advantaging one manufacturer’s product over another not only distorts the treatment-decision making process and undermines the physician-patient relationship, but also undermines the competition-based policies that are currently lowering prices and expanding patient access.
Read ASBM’s full letter here. Read the current text of H.R. 5376 here.
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| ASBM Presents at 16th Biosimilars Congregation
On December 9th, ASBM participated in the 16th Biosimilar Congregation, which focused on the Indian biosimilars market. By 2030, India is expected to become the sixth-largest market for pharmaceuticals, and has already firmly established itself in the global biopharmaceutical market. Many Indian pharmaceutical companies are preparing to step into the global biosimilars market.
ASBM was represented at the conference by Advisory Board Chair Philip Schneider, who moderated a panel on Market Access. The panel, comprised largely of representatives from Indian pharmaceutical companies, examined key challenges to gaining market access and sought to identify best practices for successfully entering tomorrow’s biosimilar market.
Topics discussed included current trends in biosimilar markets, the importance of sustainable pricing and reimbursement practices, ethical concerns, and strategies for overcoming market barriers.
A major takeaway from the discussions was that buidling confidence among physicians and patients was critical to success. To that end, panelists were strongly supportive of providing data demonstrating safety and efficacy of Indian biosimilars, including studies which showed patients may switch safely between originator products and biosimilars.
Learn more about the 16th Biosimilars Congregation here.
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| OSU College of Pharmacy Releases Second ASBM-Authored Biosimilars Course
The Ohio State University College of Pharmacy is now offering a second 1-hour Continuing Education (CE) course presented by OSU professor and ASBM Advisory Board Chair Philip Schneider, FASHP, FFIP.
The course is entitled “Biosimilar Substitution and Interchangeability”, and discusses how biosimilars are substituted at the pharmacy level in the U.S., and contrasts U.S. practices with those in other countries. The course also examines patient and physician concerns with non-medical switching, and explains the U.S.-specific concept of interchangeability. The course is ACPE accredited and available to pharmacists nationwide.
The course is the second in a series on biosimilars presented by the College of Pharmacy’s Office of Continuing Professional Development. Future course entries will examine topics including biologic pharmacovigilance and nomenclature, physician and patient perspectives on biosimilars, and the biosimilars market.
View the latest OSU CE course, “Biosimilar Substitution and Interchangeability”, here. (registration required).
View the first OSU CE Course, Biologics and Biosimilars: and Introduction, here (registration required).
Visit the OSU College of Pharmacy’s Office of Continuing Professional Development here.
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| FDA Approves Second Biosimilar Insulin
On December 17th, the FDA announced that it had approved its second biosimilar insulin product, Rezvoglar (insulin glargine-aglr). Rexvoglar is manufactured by Eli Lilly and is a biosimilar to Lantus (insulin glargine).
Like Lantus, Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
It is the 32nd biosimilar product approved in the U.S.
Learn more about the approval here.
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CMS Rescinds “Most Favored Nation” Model for Medicare Part B
On December 29th, the Centers for Medicare and Medicaid Services (CMS) published a final rule rescinding the Most Favored Nation (MFN) Model interim final rule which originally appeared in the November 27, 2020 Federal Register.
The MFN Model was scheduled to take effect January 1, 2021 but was not implemented following four lawsuits and a nationwide preliminary injunction. Opposition to the MFN rule was broad and came from many quarters including physician societies, patient advocacy organizations, the pharmaceutical industry, hospital associations, and others.
From the December 29, 2021 Federal Register entry: “After considering the comments on our proposal [to rescind the MFN Model}, we are finalizing our proposal as proposed. In this final rule, we rescind the November 2020 MFN Model interim final rule and remove the associated regulatory text at 42 CFR part 513.
The withdrawal of the MFN Model is effective 60 days after the final rule’s publication, on February 28th, 2022.
Read the final rule here.
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| UPCOMING ASBM EVENTS
ASCO-GI Meeting 2022 San Francisco, California – Janurary 20-22, 2022
World Biosimilar Congress USA 2022 San Diego, California – March 9-11, 2022
74th INN Consultation Geneva, Switzerland – April 5-8, 2022
DIA Global Annual Meeting 2021 Chicago, Illinois – June 19-23, 2022 |
