The US FDA Releases Drafts Guidance Recommending on Comparative Analytical Assessment for Biosimilars

 The US FDA Releases Drafts Guidance Recommending on Comparative Analytical Assessment for Biosimilars

The US FDA Releases Drafts Guidance Recommending on Comparative Analytical Assessment for Biosimilars

Shots:

  • The US FDA has released guidance on the design and evaluation of comparative analytical studies that are supporting demonstration of biosimilarity, with the withdrawn of previous draft guidance approach used to evaluate analytical similarity in June 2018
  • The new guidance includes improvement in analytical procedures with advancement in manufacturing science and production methods, for better targeting of the reference’s physiochemical and functional properties
  • FDA also encourages the use of state-of-the-art technology for analytical studies comprising part of a biosimilar’s application package with the submission of analytical data at IND stage as well

Click here to read full press release/ article | Ref: The US FDA | Image: ABCnews

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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