Statement by Chip Davis, President and CEO, GPhA, Regarding FDA Draft Guidance on Biosimilar Labeling

The Generic Pharmaceutical Association and its Biosimilars Council are pleased that the Food and Drug Administration (FDA) has issued its draft guidance on biosimilar labeling.

PRESS RELEASEWashington, DC - “The Generic Pharmaceutical Association and its Biosimilars Council are pleased that the Food and Drug Administration (FDA) has issued its draft guidance on biosimilar labeling. This draft guidance provides manufacturers with additional clarity needed to manufacture and distribute more affordable versions of biologic medicines for patients.

The Council is pleased that the FDA guidance takes steps to avoid confusion and in many aspects, mirrors the protocol for labeling of generic drugs. For example, a statement defining biosimilarity would be included rather than lengthy and already established scientific data proving biosimilarity. And, immunogenicity details would mirror the label content of the reference product.

GPhA and the Council are especially pleased that the proposed label contents avoid causing confusion or raising unnecessary questions about the safety and efficacy of biosimilar products. FDA recognizes that approved biosimilars meet all agency safety and efficacy standards. The draft requirements would ensure that the label reflects these core principles and provides concise, factual information. The draft guidance is a positive step to assure patients, providers and others that these products are just as safe and effective as their brand biologic counterparts. We also commend the agency for postponing guidance on interchangeable biologic labeling at this time.

GPhA and the Biosimilars Council plan to provide an expanded perspective within the FDA comment period for this guidance and look forward to working with the Agency on other outstanding biosimilar guidances.”