FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

Discussion in 'Pharma/Biotech Companies - In the News' started by cafead, May 21, 2019 at 11:23 PM.

  1. #1 cafead, May 21, 2019 at 11:23 PM
    cafead

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    via A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product.

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