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design and evaluation of comparative analytical studies that are supporting demonstration of biosimilarity- with the withdrawn of previous draft guidance approach used to evaluate analytical similarity in June 2018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