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Streamlining The Studies: New FDA Draft Guidance Aims To Speed Up Biosimilar Development
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES) to demonstrate biosimilarity in an abbreviated biologics license application (aBLA). This approach could significantly lower the cost of bringing biosimilars to market….
By: Axinn, Veltrop & Harkrider LLP