FDA moves to accelerate biosimilar approvals

FDA Releases Biosimilar Guidance Pushing to Streamline Development

The FDA releases its updated recommendations and scientific considerations for the demonstration of safety and efficacy among biosimilars and their reference products.

FDA Modernizes Biosimilar Approval to Cut Costs and Speed Access

Updated FDA policies eliminate many comparative efficacy trials, reducing biosimilar development time and cost by relying more on analytical testing.

FDA moves to accelerate biosimilar approvals

The FDA will undertake steps to accelerate the process of developing biosimilars, while also reducing development costs.

Vizient Applauds FDA’s Recent Actions to Accelerate Biosimilar Development and Lower Costs

IRVING, Texas--(BUSINESS WIRE)--Vizient® commends the U.S. Food and Drug Administration (FDA) for announcing actions to accelerate biosimilar development, including releasing new draft guidance that provides greater clarity on when comparative efficacy studies (CES) are not required for biosimilar approval which should reduce burdens currently associated with biosimilar approvals in certain circumstances. The announcement underscores the [...] T…