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Next Steps For Interchangeable Biosimilars: Lifecycle Regulation Policy Development

 
• By Sue Sutter

US FDA seeks stakeholder views on manufacturing changes, new reference product indications and other questions that build on its draft guidance for approval of interchangeable biosimilars.

The US FDA is seeking stakeholder views on how it should regulate interchangeable biosimilars over their lifecycle, in conjunction with its new draft guidance on interchangeability.

The agency is requesting input on post-approval manufacturing changes and the impact of new reference product indications on a previously licensed interchangeable product. Neither issue is addressed in the agency’s...

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