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 and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted Interchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. The webinar was the fourth in a series covering key health policy issues. The most recent of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions.  Key topics of discussion included:The importance of the interchangeable designation in building physician confidence in the prescribing and pharmacy substitution of biosimilars  The collaborative efforts by patients, physicians, pharmacists, and other stakeholders nationwide over eight years permitting the automatic substitution of biosimilars, providing they were approved as interchangeable.  The difference between the definitions of interchangeability in Europe and in the U.S.  Current legislative and administrative proposals that would weaken  the interchangeable designation or eliminate it entirely.  Speakers included:Michael Reilly, Esq. – Executive Director, ASBMRalph McKibbin, MD, FACP, FACG, AGAF – ASBM ChairmanPhilip Schneider, MS, FASHP, FFIP – ASBM Advisory Board ChairAndrew Spiegel, Esq. – Executive Director, Global Colon Cancer AssociationSteven Stranne, MD, JD- Partner, Foley Hoag LLP served as moderator of the discussion. View a recording of the webinar here.

Oregon PDAB Accepting Comments on Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars  On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) will consider a proposal to permit the automatic substitution of non-interchangeable biosimilars- that is, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently permits biosimilars that the FDA has approved as interchangeable to be automatically substituted. These have provided additional data demonstrating that safety and effectiveness do not diminish even after a patient is switched from the reference product to the interchangeable.  U.S. laws permitting biosimilar substitution of interchangeables were developed over an 8-year period based on input from patient advocacy organizations, state medical societies, and state pharmacy societies. The support of these stakeholders for biosimilar substitution was conditional on requirements that only interchangeable biosimilars would be substituted and that the physician and patient would be notified of any switch. The proposal under consideration would completely remove these provisions, meaning insurers and pharmacy benefit managers could automatically substitute a biosimilar without patient physician or knowledge.  Comments on the proposal may be submitted in a public comment form here or emailed to pdab@dcbs.oregon.gov

ASBM Comments on FDA Draft Guidance Removing Interchangeability Statement from Interchangeable Biosimilars On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. Under U.S. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. This is due to their having provided additional data to the FDA demonstrating that the safety and efficacy aren’t diminished even after repeated switching with the original biologic. The agency has approved 44 biosimilar products, including seven interchangeable biosimilars.  From the comments: ASBM respectfully disagrees that the interchangeability statement is not valued by prescribing health care professionals. In a survey of 400 US physicians who prescribe biologics, participants were asked how important it is that the product label clearly indicates that a biosimilar is or is not interchangeable; approximately 80% of physicians rated the importance of this either a 4 or 5 on a 5-point scale. Likewise, a survey of over 400 pharmacists indicated that almost 90% of those polled rated the importance of the product label clearly indicating that a biosimilar is or is not interchangeable as a 4 or 5 on a 5-point scale. ASBM believes FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy- level substitution of that biosimilar in place of the prescribed originator. Only a third of physicians surveyed indicated that an interchangeable designation would not affect their prescribing behaviors. Read the new FDA Guidance here.  Read ASBM’s comments on the guidance here.

ASBM Releases Statement on CMS Proposal to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars Update: Comments Due January 5, 2024 On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. The policy change represents a stark departure from the perspectives of the U.S. medical community and patient advocacy organizations, a decade of state-level policymaking, and CMS’ recent assurances, according to the Alliance for Safe Biologic Medicines. “Substitution of biosimilars by someone other than the prescribing physician is a controversial practice banned in many countries, including nearly all of Western Europe”, says ASBM Executive Director Michael Reilly, who served as Associate Deputy Secretary of Health and Services during the development and implementation of the Part D prescription drug benefit. “It is also opposed by the majority of physicians, in the U.S. and worldwide.” A 2021 survey of 401 U.S physicians found that while 89% of U.S. prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. cost, coverage) reasons- as would occur under the proposed CMS rule. Further, 69% consider it very important or critical that physicians, with their patient, make these treatment decisions. “Treatment plans aren’t one-size fits all”, explains ASBM Chairman and practicing gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF. “Patients often try several products over years before finding the one that best stabilizes their condition. As doctors and patients, we’re reluctant to switch a patient’s medicine unnecessarily and risk losing those gains.” U.S. state laws nationwide permit pharmacy-level substitution of “interchangeable biosimilars”- those for which the manufacturer has provided additional safety and efficacy data to the FDA showing that a patient who’s been switched to the interchangeable product will have the same results as staying on the originator product. These laws were passed state by state over the past decade with the support of physician societies and patient advocacy organizations- contingent on assurances that only interchangeable biosimilars would ever be substituted without physician approval. CMS is accepting public comments on the Proposed Rule. They may be submitted here and are due by January 5, 2024 Read the full statement here.

ASBM Exhibits at ACR Convergence 2023 From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. ACR Convergence is hosted annually by the American College of Rheumatology and is considered the premier meeting for rheumatology professionals globally. ASBM was represented at the booth by Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Programs Director Ray Patnaude.  Visitors to the booth learned about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines.  Learn more about ACR Convergence 2023 here.