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’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the way generics are. Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a response published in GaBI Journal. The FDA comments echo language in the Administration’s FY2025 HHS Budget which alleges the interchangeable standard creates “confusion” among healthcare providers. On the contrary, Reilly explains, it creates confidence: The interchangeable standard, through its additional data requirements, reassures physicians that switching won’t reduce treatment efficacy: 59% are more comfortable with an interchangeable being substituted at the pharmacy. “Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such. 50 U.S. state legislatures were not confused when they passed legislation limiting pharmacy substitution only to interchangeable biosimilars”, says Reilly. “These were supported by state medical societies conditional on these assurances. Breaking this commitment to physicians would be an unconscionable bait-and-switch by policymakers.” Moreover, while the Administration claims eliminating the distinction would bring the U.S. more into line with European substitution practices, in fact the opposite is true: The EMA does not weigh in on pharmacy substitution of biosimilars; this is reserved for member states and nearly every Western European country has decided (like U.S. states) that this is not acceptable. A 2019 survey revealed a strong majority (73%) of Europe’s physicians, like their U.S. counterparts, oppose third-party biosimilar substitution. Finally, biosimilar uptake is largely determined by insurer and PBM formulary design, not a biosimilar’s interchangeable designation, Reilly explains. “CVS Caremark, which controls 34% of the market, recently dropped the reference adalimumab in favor of its own co-branded biosimilar version. Within a week, adalimumab biosimilar market share rose from 5% to 36%, lack of automatic-substitutability by a pharmacist posed no obstacle”. Cigna, a PBM controlling 24% of the U.S. market, has announced plans to make a similar move in June. “The interchangeable biosimilar standard is working as intended: building physician confidence through data and providing a biosimilar option physicians can be certain will not jeopardize the treatment stability of a patient for whom maintaining it is a critical concern.There are several promising bipartisan legislative efforts underway in Congress bring more transparency to PBM formulary design and rebate practices. These represent a far more productive -and medically appropriate- target for reform efforts for those seeking to boost biosimilar uptake.” Read the article in GaBI Journal here. |
| ASBM Comments Urge EMA Not to Abandon Clinical Data in Biosimilar Approvals On April 30, ASBM submitted comments to the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) as part of a public consultation periodon the Agency’s “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development”. The document expresses the EMA’s intent to streamline biosimilar development by re-evaluating the role of clinical safety and efficacy data. Read the concept paper here. Read ASBM’s comments here. |
| FDA Celebrates 50th Biosimilar Approval On April 25, the FDA approved its 50th biosimilar. Its announcement was accompanied by a statement touting the many successes of the U.S. biosimilar program since the first approval in 2015, including savings to the U.S. health system and increased access to biologic treatments for patients. From the FDA statement: According to a 2023 report by the Association of Accessible Medicines, FDA-approved biosimilars have saved the health care system $23.6 billion since the first biosimilar product was approved in 2015. Collectively, patients have used biosimilars for almost 700 million days of therapy, 344 million days of which patients received care they otherwise may not have received. The impact and potential of biosimilars are significant not only in terms of savings to the health care system, but also for health equity and helping improve patients’ access to medications that were previously beyond their reach. Read the FDA’s statement on this milestone here. |
| ASBM Chairman Urges State and Federal Lawmakers to Help Ensure Patient Access, Treatment Choice In early April ASBM Chairman Ralph McKibbin joined with the Pennsylvania Nonmedical Switching Coalition to meet with members of the Pennsylvania House of Representatives Insurance committee to answer questions and advocate regarding the impact of nonmedical switching on patients in the state. PA State Senate bill 348 amends the Unfair Insurance Practices Act to prevent nonmedical switching and a House companion bill is pending. Dr. McKibbin also participated as part of the American College of Gastroenterology Board of Governors in their legislative action session April 17-19 in Washington, DC. Meetings were held with both U.S. Senate and House members to advocate for patient access to care. During the educational session, Dr. McKibbin presented on the importance of the leadership provided by stakeholder organizations. |
| UPCOMING EVENTS ASCO Annual MeetingChicago, IL – May 31-June 4, 2024 BIO International Meeting San Diego, CA – June 3-6, 2024 DIA Global Annual Meeting San Diego, CA – June 16-20, 2024 ACR Convergence 2024 Washington, DC – November 14-19, 2024 |
