FDA releases draft guidance for biosimilars

SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

The Patient Protection and Affordable Care Act of 2010 contained a provision for an abbreviated regulatory approval pathway for biosimilars, but the task of creating regulations for them was left to the FDA itself. The guidance documents released Thursday include scientific considerations for helping companies demonstrate that a proposed biosimilar is similar to the original branded version, quality considerations for demonstrating biosimilarity and a document with common questions and answers.

"When it comes to getting new biosimilar products on the market, [the] FDA has taken an innovative approach to supporting their development at every step of the pores," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "These draft documents are designed to help [the] industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."

The generic drug industry, which has long pushed for a biosimilar pathway, praised the release of the draft guidance. "GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients," a statement released by the Generic Pharmaceutical Association read.

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