Comments to FDA Stress Need for Clinical Trials, Restraint for Interchangeability Designations, and Unique Names for Biosimilar Products

Washington, D.C. — In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA that outlined recommended steps to ensure that patient safety is at the forefront of the biosimilars pathway.

While the FDA’s proposed framework demonstrates the agency’s thoughtful approach, ASBM stated in its comments that effective implementation of the biosimilars pathway must incorporate prudent measures, including:

  • Analytical data and clinical studies to fully characterize the biosimilarity and immunogenicity of a biosimilar product;
  • Traceability measures, including unique nonproprietary names for all biologic therapies, transparent product labels and patient/physician notification to enable clinical assessment and adverse event reporting; and
  • Before designating a biosimilar ‘interchangeable’ with its reference product, U.S. regulators must recognize, and address, that the similarity between the reference product and its interchangeable biologic product(s) may change over time as a result of manufacturing or environmental variations.

Within its comment letter, the Alliance for Safe Biologic Medicines outlines clear, concrete, and achievable ways to manage risk and thereby prioritize patient safety.

Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines released the following statement as he submitted the coalition’s comments to the docket:

We are pleased with the FDA biosimilar draft guidance but it leaves a lot of questions unanswered — particularly when it comes to the requirement of clinical studies and pharmacovigilance.

There can be no grey area when it comes to patient safety. Unwanted immunogenicity is the preeminent safety challenge associated with biological therapeutics and can result in unexpected or sometimes severe adverse effects.

The predictive value of animal studies is often insufficient to characterize immunogenicity in humans. Clinical studies, in addition to analytical methods, are necessary to weed out ineffective and unsafe drugs — innovator biologics and biosimilars — before they are ever a risk to patients.

In the unfortunate situation that problems arise, measures must be in place to accurately and promptly connect a specific patient to a specific product. Our current pharmacovigilance system is not equipped to distinguish a biologic reference product from its biosimilars. Unique nonproprietary names for biosimilar and innovator compounds ensure we will be able to effectively track and trace a product to an adverse event. This must be implemented prior to biosimilar market entry.

The Alliance for Safe Biologic Medicines will continue to work with the FDA to outline an approval pathway that enables physicians to confidently prescribe biosimilar medicines.

On February 9, the FDA released draft guidance on the biosimilars approval pathway and requested written comments by April 16.

To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email


About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond. Visit us at