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29 Feb 2024

What is 351(k) biologics license application (BLA)?

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351(k) biologics license application is the biosimilar application process in USFDA. Manufacturers must submit 351(k) biologics license application (BLA) to have a product reviewed as a biosimilar or interchangeable.

The 351(k) pathway is related to biosimilar products. Biosimilars are biological products that are highly similar to, but not identical to, an already approved reference biological product. To gain approval through the 351(k) pathway, a manufacturer must submit a Biologics License Application (BLA) that demonstrates the biosimilarity of the product to the reference product.

Details which need to be submitted under 351k BLA

  • Analytical studies demonstrating that the biological product is “highly similar” to the reference product notwithstanding minor differences in clinically inactive components;
  • Animal studies (including the assessment of toxicity); and
  • A clinical study or studies (including the assessment of immunogenicity and pharmacokinetics (PK) or pharmacodynamics (PD)) sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and for which licensure is sought for the biosimilar product.

FDA may determine, in its discretion, that an element described above is unnecessary in a 351(k) BLA.

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