Biosimilars: FDA Closes Out 2016 With Clinical Pharmacology Guidance
While industry awaits US FDA guidance on interchangeability, agency finalizes document on clinical pharmacology data to support a demonstration of biosimilarity – years ahead of May 2019 target date in commitment letter for user fee program's renewal.
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Draft guidelines on interchangeability and statistical considerations due by end of 2017, suggesting long-awaited documents may not see the light of day this year as many had hoped.
Industry objects to proposal that certain protein product applications pending as of March 23, 2020, will have to be resubmitted as BLAs – and to the idea that transitioned products will lose non-orphan exclusivity.
Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.