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FDA: Three Final Guidance Documents on Biosimilarity
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FDA: Three Final Guidance Documents on Biosimilarity

Following a three years period since publishing the “Biologics Price Competition and Innovation Act” and therein the “Approval Pathway for Biosimilar Biological Products”, the FDA has now finalized the following three guidance documents on Biosimilars:

Guidance for Industry - Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Guidance for Industry - Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Guidance for Industry - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.


According to the FDA, a biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. The expectations for biosimilar products are extremely high.

The first guidance, a Q&A-document, provides answers to common questions on

  • Biosimilarity or interchangeability
  • Provisions related to requirements to submit for a “biological product”
  • Exclusivity

The second document focuses on the quality considerations companies need to take into account when assessing whether a biosimilar and its reference product are highly similar. This requires appropriate analytical methodology that has adequate sensitivity and specificity to detect and characterize the differences.

The third guidance gives an overview on how to determine biosimilarity and discusses important scientific considerations in demonstrating biosimilarity by using scientific data. This includes:

  • A stepwise approach
  • The totality-of-the-evidence approach
  • General scientific principles.

If you are interested in more information for Industry on Biosimilars please click here.


FDA: Biosimilars

FDA: Newly added guidance documents

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