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Biosimilar Pathway Not Smooth For Some Early Applicants

 
• By Derrick Gingery

FDA says some candidates have appeared so different from their reference products that sponsors were told the molecule could not be a biosimilar.

FDA has lauded the increasing industry interest in biosimilars as it has rolled out new guidances and user fees supporting the program, but it does not appear that all sponsors are seeing a smooth regulatory path.

Some candidates have not been judged adequately similar to their reference products at the IND stage, pushing the agency to flat out reject them as potential biosimilars.

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