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Taking Biosimilars ‘To The Next Level’

IGBA Wants Discussion To Advance On A More Tailored Development Program

 
• By Dave Wallace

The IGBA wants to take discussions around streamlining biosimilar development to “the next level”, the association tells Generics Bulletin.

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The IGBA wants to take discussions on streamlining biosimilar development to the next level • Source: Shutterstock

Biosimilar development pathways are currently a hot topic in the off-patent industry. Established global processes for developing and registering biosimilar drugs are coming under fresh scrutiny as industry stakeholders reassess the need for certain data typically submitted to regulators as part of a biosimilar sponsor’s application.

Recent moves in the UK to do away with the need for a comparative efficacy trial for biosimilars have caught industry’s eye. (Also see "UK To Diverge On Biosimilar Data Requirements" - Generics Bulletin, 25 September, 2020

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