BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency

New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.

Team efficiency
Quicker, targeted advice on from the FDA is expected to help speed biosimilar development. • Source: Alamy

Biosimilar sponsors like the new user fee agreement because of its potential to reduce the number of necessary formal meeting requests and by extension speed development.

BsUFA III will create a new meeting type allowing sponsors to schedule a discussion with the US Food and Drug...

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