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design and evaluation of comparative analytical studies that are supporting demonstration of biosimilarity, with the withdrawn of previous draft guidance approach used to evaluate analytical similarity in June 2018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