February 6, 2026 The Alliance for Safe Biologic Medicines (ASBM) welcomes FDA Commissioner Marty Makary’s comments on the social media platform X affirming that “the FDA cannot verify the quality, safety, or effectiveness of non-approved drugs” and warning that the agency will “take swift action against companies mass-marketing illegal copycat drugs.” These remarks accurately reflect […]
On January 12, the Brussels-based GaBI Journal published an editorial by ASBM Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Steering Committee member Andrew Spiegel examining an abrupt and troubling shift in U.S. biosimilars policy. In the article, the authors argue that while biosimilars have consistently demonstrated safety and effectiveness, they are not […]
On January 20, ASBM submitted formal comments to the U.S. Food and Drug Administration on the agency’s October 2025 draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. In the comments, ASBM supports FDA’s recognition that comparative analytical assessments (CAA) have become increasingly […]
On December 12th, ASBM and the Global Colon Cancer Association (GCCA) hosted a one-hour webinar discussing the 340B Drug Discount Program, a federal program designed to help hospitals and clinics serving patients in need. The webinar, entitled “Reforming 340B: Ensuring the Discount Program Delivers for Patients” discussed how the program has strayed from its original mission- […]
The world’s regulators agree: Biosimilars aren’t generics. Why is the FDA suddenly pretending they are?
What is MFN?—Why It’s a Threat to Patients The Most Favored Nation (MFN) drug pricing policy ties U.S. medicine prices to those in countries with strict government price controls. This may sound like a win for patients, but MFN imports the very systems that limit access, delay innovation, and lead to higher death rates abroad—especially […]
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 period on 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 […]
February 6, 2026 The Alliance for Safe Biologic Medicines (ASBM) welcomes FDA Commissioner Marty Makary’s comments on the social media platform X affirming that “the FDA cannot verify the quality, safety, or effectiveness of non-approved drugs” and warning that the agency will “take swift action against companies mass-marketing illegal copycat drugs.” These remarks accurately reflect […]
On January 20, ASBM submitted formal comments to the U.S. Food and Drug Administration on the agency’s October 2025 draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. In the comments, ASBM supports FDA’s recognition that comparative analytical assessments (CAA) have become increasingly […]
On January 12, the Brussels-based GaBI Journal published an editorial by ASBM Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Steering Committee member Andrew Spiegel examining an abrupt and troubling shift in U.S. biosimilars policy. In the article, the authors argue that while biosimilars have consistently demonstrated safety and effectiveness, they are not […]
On December 12th, ASBM and the Global Colon Cancer Association (GCCA) hosted a one-hour webinar discussing the 340B Drug Discount Program, a federal program designed to help hospitals and clinics serving patients in need. The webinar, entitled “Reforming 340B: Ensuring the Discount Program Delivers for Patients” discussed how the program has strayed from its original mission- […]
Reforming 340B: Ensuring the Discount Program Delivers for Patients December 12, 2025 • 11:00 AM – 12:00 PM ET Hosted by the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) Register Now The 340B Drug Discount Program was created to help hospitals and clinics stretch limited resources to serve […]
The world’s regulators agree: Biosimilars aren’t generics. Why is the FDA suddenly pretending they are?
Biologic medicines are used to treat millions of patients with serious illnesses like cancer, arthritis, and psoriasis. The patents for many biologic therapies are expiring, and biosimilars are entering the marketplace. These give patients new treatment options, and reduce costs through competition. Regulatory authorities around the world have put policies in place to ensure that biosimilars have been appropriately tested, and are safe and effective for patients.
Non-Medical Switching
Non-Medical Switching is when a patient is switched from one biologic medicine (either an originator product or a biosimilar) to another product- not for reasons of health or safety but for economic reasons. This is often done by a third party such as a private insurer, a pharmacy-benefit manager, or a government agency in order to save money, increase profits, or because of a deal made with a particular manufacturer. This practice is controversial among patients and physicians because treatment decisions are not "one size fits all". Many patients try several biologic medicines until they find one that stabilizes their condition; physicians generally oppose the unnecessary switching of medicines for stable patients.
The Alliance for Safe Biologic Medicines (ASBM) is a diverse coalition of stakeholders, including physicians, pharmacists, patient advocates, researchers, and biopharmaceutical manufacturers. Since 2010, ASBM has worked with regulators worldwide to shape policies that reflect the best interests of patients, ensuring access to lifesaving and life-enhancing medicines while fostering innovation in healthcare.
