FDA´s Action Plan for Biosimilars

The U.S. Food and Drug Administration, FDA, has published its Biosimilars Action Plan in July 2018. To further improve coordination and support of all activities related to biosimilar and interchangeable product development and approval, FDA is in the process of transferring the TBBS (Therapeutic Biologics and Biosimilars Staff) to the Office of Therapeutic Biologics and Biosimilars (OTBB). The transfer to OTBB will:

  • Improve FDA´s efficiency in providing development-phase advice to product developers and reviewing application materials, including enhanced pre- and post-submission communication with individual applicants; and
  • Support efficient policy development and implementation through the creation of additional guidance documents for product developers.

Therefore, FDA is prioritizing the development of the following guidances:

  • Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (Public Health Service Act ),
  • Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009,
  • Considerations in Demonstrating Interchangeability with a Reference Product,
  • Statistical Approaches to Evaluate Analytical Similarity,
  • Processes and further considerations related to post-approval manufacturing changes for biosimilar biological products.

Furthermore, the FDA is developing a proposed rule on the interpretation of the definition of "biological product" which would provide additional clarity and predictability for sponsors regarding the appropriate review pathway for such products. To improve regulatory clarity, the FDA is evaluating its regulations regarding the submission and review of BLAs (Biologics License Applications) to ensure that they account for current practices and authorities.

Additionally, the FDA recently published its final guidance on Labeling for Biosimilar Products.

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