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  8. Biosimilars | Science and Research
  1. Biosimilars

Biosimilars | Science and Research

The U.S. Food and Drug Administration is responsible for protecting the public health through the rigorous review of applications for licensure of biological products, including biosimilar and interchangeable biological products. In addition, FDA is responsible for advancing the public health by helping to speed innovations, including by exploring state-of-the-art ways to produce scientific evidence in support of biosimilar and interchangeable product development.

FDA supports research projects that enhance biosimilar and interchangeable product development and regulatory science. Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), FDA will pilot a regulatory science program that focuses on advancing the development of interchangeable products and improving the efficiency of biosimilar product development. FDA is committed to enhancing regulatory decision making and facilitating science-based recommendations in areas foundational to biosimilar and interchangeable product development.

Advancing the development of biosimilar products may include:

  • Enhancing the identification and risk assessment of relevant product, excipient, and container closure attributes; better defining acceptable differences in attributes between the reference product and the proposed biosimilar product; advancing analytical tools to detect relevant differences; and facilitating the comparative analytical assessment with enhanced statistical methodologies
  • Advancing clinical trial design
  • Leveraging in silico and in vitro methodologies in the comparative immunogenicity assessment
  • Developing broadly applicable approaches for the use of pharmacodynamic markers

Advancing the development of interchangeable products may include:

  • Researching methodologies to assess the potential impact of differences between the reference products and interchangeable products, such as product container closures and associated devices
  • Researching approaches other than switching studies to meet the interchangeability standard (e.g., considering whether it might be possible to leverage real-world evidence, including health data derived from medical claims, electronic health records, data captured using digital tools, data from registries, and other sources)
  • Researching the use of in vitro and in silico methods to evaluate immunogenicity that may support a demonstration of interchangeability between the reference product and the proposed interchangeable product

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