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For Biosimilars, A Mid-Review Cycle Product Quality Discussion Appears To Be A Bad Omen

 
• By Derrick Gingery

Only about one-third of biosimilars received a first-cycle approval from US FDA after product quality discussions during the mid-assessment-cycle meeting, according to an interim report on the biosimilar application review program.

scientist working with vat in lab
The report also indicated BPD Type IV meetings were valuable to biosimilar sponsors. • Source: Shutterstock

Product quality questions raised during a biosimilar application mid-assessment cycle meeting appear to be a strong signal that the US Food and Drug Administration may issue a complete response letter.

The first-cycle approval rate for biosimilar applications when a product quality issue was discussed during a mid- or late-assessment cycle meeting was far lower than when US Food and Drug Administration officials raised other issues, according to an

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