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Statement by Chip Davis, President and CEO, GPhA, Regarding FDA Draft Guidance on Biosimilar Labeling

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (April 1, 2016) — “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Association and its Biosimilars Council are pleased that the Food and Drug Administration (FDA) has issued its draft guidance on biosimilar labeling. This draft guidance provides manufacturers with additional clarity needed to manufacture and distribute more affordable versions of biologic medicines for patients.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 The draft guidance is a positive step to assure patients, providers and others that these products are just as safe and effective as their brand biologic counterparts.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.”


About the GPhA Biosimilars Council
The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.