Acting FDA Commissioner Committed to Bringing Biosimilars to Market

Agency providing ‘final guidance’ along pathway

Last week, the FDA took significant action toward helping promote competition in the biologic market by providing final guidance on the pathway for “interchangeable” biologics, which may be substituted without the involvement of the prescriber, similar to how generic drugs are routinely substituted for brand name drugs when they are prescribed for patients.

According to an agency press release, biologics provide important treatment options for patients with serious diseases like cancer, rheumatoid arthritis, diabetes and multiple sclerosis. The FDA’s final guidance on interchangeability will provide clarity for developers who want to demonstrate that their proposed biological product meets the statutory interchangeability standard under the Public Health Service Act (PHS Act).

The final guidance offered critical overview of important considerations and explained scientific recommendations. Once an application or supplement seeking licensure as an interchangeable product is submitted, the FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement is sufficient to meet the applicable statutory standard.

Later this week, the agency plans to meet with patients, advocates, and the industry at large about additional factors to consider for insulin products.


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