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.
| Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications. The opinion highlights concerns that this bill might be included in the end of year continuing resolution bill, without properly considering the impacts on patients. The bill would classify all biosimilars as interchangeable, allowing them to be substituted at the pharmacy level without physician approval, as if they were generics (which they are not). It would also remove the FDA’s authority to ask for additional studies when needed. Currently, biosimilar sponsors must demonstrate to the FDA that switching will not affect treatment safety or efficacy before third parties like insurers or pharmacy-benefit managers (PBMs) can substitute a biosimilar. The bill would remove these guardrails, Reilly explains: However, if passed, the Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable without requiring additional analysis or data. Insurers and pharmacy benefit managers (PBMs) nationwide would be able to switch patients to their preferred – and often most profitable – products regardless of “interchangeable” designation. Inappropriate switching may affect treatment stability and safety for patients. Proponents of the bill have continuously cited alarming factual errors that suggest even the sponsors do not understand the science or the implications of this policy. The sponsors have falsely claimed that biosimilars are “equivalent” to generics; yet the FDA says, “biosimilars are not generics and important differences exist between them.” Supporters of the bill claim that clinical switching studies are required to substitute interchangeable biosimilars at the pharmacy when, in fact, the FDA has broad discretion on what data is required. A majority of interchangeable biosimilars were approved without such studies. Additionally, supporters of this bill incorrectly claim that loosening the standards for interchangeability will align U.S. policy with Europe. Contrary to what supporters of the bill claim, this policy will not align U.S. biosimilar regulations with those in Europe. The European Medicines Agency (EMA) refers to “interchangeability” as prescription substitutions by physicians and not third-party substitution of biosimilars at the pharmacy counter – a practice that is rare and frequently banned in European countries. U.S. physicians, who are experts in prescribing these treatments, overwhelmingly oppose the bill’s provisions. A recent survey found that 88% support individual evaluations for biosimilar interchangeability, and the same percentage see switching studies as essential to increasing confidence in these medicines. Only 11% of physicians support the FDA deeming all biosimilars as interchangeable without further data, as this bill would mandate. Read the full op-ed here. |
| ASBM Responds to PBM Industry Endorsement of Biosimilar Red Tape Elimination Act On December 9th, ASBM released a statement in response to the recent call by the Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers (PBMs), that urged passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035). ASBM has consistently opposed the bill, which would eliminate the FDA standards biosimilars must currently meet in order for third-parties like PBMs to substitute them at the pharmacy level. This change would lead to widespread third-party substitution of all biosimilars, jeopardizing treatment stability for millions of patients and undermining physician confidence in biosimilar substitution. From the statement:The Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust. Since the bill was introduced, ASBM has worked to educate physicians, patients, and policymakers on how the legislation would dangerously undermine FDA safety standards.“Biosimilars are safe and effective but they are not generics; they are highly similar but not identical to their reference products. “This bill would allow PBMs to substitute the prescribed medicine with the product that is most profitable for the pharmacy or PBM without physician oversight or approval,” said ASBM Executive Director Michael Reilly, who helped oversee FDA operations during his tenure as Associate Deputy Secretary in the U.S. Department of Health and Human Services (HHS). “Third-party automatic substitution introduces risks, especially for patients with chronic conditions who depend on maintaining treatment stability.”Supporters of the bill have misrepresented key facts in order to garner support. Claims by supporters of the bill that 1) biosimilars are equivalent to generics and that 2) under this bill U.S. policy would align with European standards are demonstrably false. According to the FDA, biosimilars differ significantly from generics and require an approval framework consistent with the science. Furthermore, in most European countries, automatic substitution at the pharmacy level is rare and often banned.Read the full statement here. |
| ASBM Exhibits at ACR Convergence 2024 During November, ASBM was proud to again participate in the American College of Rheumatology (ACR) Convergence 2024, held from November 14-19 in Washington, DC. ACR Convergence is known as the world’s premier annual rheumatology gathering. ASBM exhibited in the conference’s patient pavilion from November 15-18, and was represented at the meeting by Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Programs Director Ray Patnaude. ASBM’s booth featured a variety of materials ASBM has developed over the past year on issues including interchangeable biosimilars and the Inflation Reduction Act; as well as a monitor playing recent ASBM webinars on these and other topics. Joining ASBM as exhibitors were ASBM member organizations including the Lupus and Allied Diseases Association (LADA) and Ai Arthritis. Read more about ACR Convergence 2024 here. |
| FDA Approves 63rd Biosimilar, Its 17th in 2024 In December, the FDA approved its 63rd biosimilar, Steqeyma (Ustekinumab-stba). Steqeyma is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. The approval of Steqeyma brings the total number of biosimilars approved in 2024 to 17. Read about the approval here. View all approved FDA biosimilars here. |
| ASBM Resource Recap: Biosimilar Red Tape Elimination Act As a part of ASBM’s ongoing educational efforts surrounding S.2035, the Biosimilar Red Tape Elimination Act, we have recently released several resources for policymakers and the general public. These include:A Myth vs. Fact sheet which highlights several serious factual errors and misinformation used in efforts to promote and gain support for the bill. Op-ed from ASBM Executive Director Michael Reilly (RealClearHealth)Op-ed from ASBM Chairman Ralph McKibbin MD (Altoona Mirror)An October 31st Webinar ASBM/Generics and Biosimilar Initiative For more ASBM educational materials on the Biosimilar Red Tape Elimination Act click here. |
| UPCOMING EVENTS WHO 80th INN Consultation Geneva, Switzerland – March 18-21, 2025 DDNC Annual MeetingLos Angeles, CA – May 17-21, 2025 ASCO Annual MeetingChicago, IL – May 30-June 3, 2025 DIA Global Annual Meeting Washington, DC – June 15-19, 2025 BIO International Convention Boston, MA – June 16-19, 2025 |
