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.

ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. ASBM was well represented at the conference, with several member groups were in attendance including the International Cancer Advocacy Network (ICAN), and the Global Colon Cancer Association (GCCA). Executive Director Michael Reilly also attended the conference, where he met with representatives of the cancer community and discussed the IRA’s likely negative impacts on cancer drug research and development, biosimilar competition, and patient access to new innovative therapies.  In conjunction with ASCO 2024, ASBM released a resource guide for the cancer community, which assembles a variety of ASBM-created educational content detailing the IRA’s effects. These include a webinar featuring an analysis of the policy by former government health officials responsible for developing and implementing Medicare’s prescription drug benefit, a podcast episode, a research paper, a fact sheet, and a patient-education microsite.    View the resource guide here.

ASBM Discusses Biosimilar Interchangeability and Substitution at Oregon’s St. Charles Health System Grand Rounds On May 17,  ASBM Executive Director Michael Reilly led a Grand Rounds at St. Charles Health System focused on biosimilar interchangeability and substitution. The Bend, OR-based health system is the state’s largest.  Among the topics Reilly covered were recent efforts at the state, federal, and international level to eliminiate the distinction between biosimilars (which may be substituted in place of their reference product by a prescribing physician) and interchangeable biosimilars, which may be substituted under state laws by a pharmacist. Interchangeables have earned this classification by providing additional data to the FDA demonstrating that neither safety nor efficacy diminish for patients, even after repeated switching, relative to patients who remained on the reference product.  This discussion is particularly relevant for Oregon healthcare providers as last year, the states’s Prescription Drug Affordability Board (PDAB) recommended the Oregon legislature alter state law 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 only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.  ASBM submitted comments opposing the proposal and defending the current state law. From the comments: As Congress and the FDA intended, the interchangeable biosimilar designation has proven successful in promoting confidence in biosimilars, and in their automatic and third-party substitution: 57% of physicians said they’d be more likely to prescribe an interchangeable biosimilar; 59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator.States like Oregon were able to gain physician support for their biosimilar substitution legislation due to the assurances provided in the legislation that only interchangeable biosimilars would be substituted without prescriber approval. They were able to secure support from patient advocacy organizations conditional on patients being notified if their medicine were to be switched. The proposal under consideration by the PDAB strikes at the heart of these reasonable protections, and betrays the promises made to physicians and patients.  View Mr. Reilly’s Grand Rounds presentation here.  Read ASBM’s comments on the OR PDAB legislation here.

ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars  On May 10th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published an article by ASBM’s Executive Director Michael Reilly entitled “Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars”. The article was written in a response to an April article in EndpointsNews, in which 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 Reilly.  The FDA official’s comments echoed 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%.” 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 effortsunderway 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.

FDA Approves First Interchangeable Biosimilar for Two Rare Diseases On May 28th, the U.S. FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; andthe treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.“Many rare conditions are life-threatening, and many do not have treatments,” said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to help facilitate the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited.”  Read approval the FDA approval here.

FDA Approves First Interchangeable Biosimilars to Treat Macular Degeneration In May, the FDA approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as interchangeable biosimilars to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye. By blocking VEGF, aflibercept products can slow down or reduce damage to the retina and help preserve vision. Both Yesafili and Opuviz are used to treat:Neovascular (wet) age-related macular degenerationMacular edema following retinal vein occlusionDiabetic macular edemaDiabetic retinopathyBoth Yesafili and Opuviz are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution to treat patients for the conditions listed above according to dosing regimens as recommended in the labeling. Read more about the FDA approvals here.

Pennsylvania Senate Introduces PBM Bill  The Pennsylvania Senate Health and Human Services Committee recently unanimously amended SB 1000, An Act amending the act of November 21, 2016 (P.L.1318, No.169), known as the Pharmacy Audit Integrity and Transparency Act; It was introduced and referred to the Committee on January 8th of this year and has now been presented for first consideration. Senate Bill 1000 directs the Insurance Department to develop a process for hearing and resolving pharmacy complaints against a PBM. PBMs shall report to the department the amount of rebates and payments received from drug manufacturers, and how those rebates and payments were distributed by the PBM. The legislation will also limit or ban several practices by PBMs, including patient steering, spread pricing and retroactive recoupment of money paid by the PBM to the pharmacy. Read more about PA SB 1000 here.