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While the FDA prepares to hold its first discussion on the scientific issues surrounding follow-on biologics this month, European health officials are preparing a guidance that will let generic firms seek approval for biosimilar products as soon as next fall.
The FDA should delay its decision on a widely watched follow-on biologics application until after the agency holds a meeting next month on the scientific issues related to follow-on biologics and develops a draft guidance next year on how to approve versions of the complex proteins, according to Pfizer.
While generic drugmakers are urging the FDA and Congress to develop an approval pathway for generic biologics, some firms already are marketing the products.
The FDA will not release its draft guidance detailing the scientific issues on follow-on biologics this summer as originally announced, according to a top agency official who also said the FDA will not approve generic biologics for products that can’t be characterized.
For the FDA to approve a generic biologic, the agency would have to rely on an innovator firm’s trade secret data covering the product’s manufacturing process — something that is prohibited by law, argues biotech firm Genentech.
The FDA’s acting commissioner said the agency has no choice but to remain open-minded about generic biologics after a U.S. senator urged the FDA to address the legal and regulatory foundations before releasing a scientific guidance for producing the complex products.
The generic drug industry is moving closer to tapping into the nearly $10 billion worth of biological products going off patent in the next five years. The FDA is expected this spring to release a guidance on the scientific challenges in creating generic biologics.