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  1. FDA In Brief

FDA In Brief: FDA Issues Draft Guidance on Biosimilar Licensing and Labeling, Timing of Certain Supplement Reviews

February 6, 2020

Media Inquiries

  Jim McKinney
  240-328-7305

The following quote is attributed to Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research:

“Applicants seeking licensure of a proposed biosimilar or interchangeable biosimilar generally do not have to wait to submit their application because a subset of the reference product’s licensed conditions of use is protected by unexpired exclusivity or patents."

“That’s why the FDA is issuing draft guidance that, when finalized, will provide recommendations relevant for manufacturers seeking licensure of a proposed biosimilar or interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use."

“Issuance of this guidance is part of the FDA’s ongoing efforts to support the development of biosimilar and interchangeable biosimilar products by providing additional clarity to applicants, which the FDA expects will improve access to these vital therapies for patients who need them. ”

  • Today, the U.S. Food and Drug Administration published a draft guidance, “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product has been Licensed.” When finalized, this guidance will provide recommendations on, among other things, how to prepare draft labeling for manufacturers seeking licensure of a biosimilar or interchangeable biosimilar product for fewer than all of the reference product’s licensed conditions of use, as well as recommendations for submitting supplements to a licensed biologics license application that seek to add a condition of use for which the reference product has been licensed.
  • The draft guidance also states that, to the extent practicable, the FDA intends to target a six-month timeline for reviewing supplements seeking licensure of a biosimilar or interchangeable biosimilar product for an additional condition of use that has been previously licensed for the reference product. This would not alter the goal dates described in the Biosimilar User Fee Amendments (BsUFA) II Goals Letter.
  • Developing guidance on this topic fulfills a priority deliverable in the FDA’s Biosimilars Action Plan (BAP); the BAP aims to improve the efficiency of the biosimilar and interchangeable biosimilar product development and approval process and to maximize scientific and regulatory clarity for the biosimilar and interchangeable biosimilar product development community.
  • The FDA will begin accepting comments from the public on the draft guidance for 60 days beginning Feb. 7.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.