Biologics

FDA Awards 5 Biosimilars Research Grants

David McFarland

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FDA has announced five research grants made under the Biosimilar User Fee Act (BsUFA) research grant program in the areas of (1) improving the efficiency of biosimilar product development and (2) advancing the development of interchangeable products. The five grants are:

  • assessment of the performance of multi-attribute method versus conventional quality control methods for evaluation of product quality attributes of adalimumab and etanercept;
  • platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulations;
  • systematic analytical characterization of innovator and biosimilar products with the focus on post-translational modifications;
  • ISPRI-HCP: CHO protein impurity immunogenicity risk prediction for improving biosimilar product development and assessing product interchangeability; and
  • improving the efficiency of regulatory decisions for biosimilars and interchangeable biosimilars by leveraging real-world data.

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