FDA Developments on Biosimilars

The text is an FDA guidance to applicants regarding changes in the manufacture of approved biosimilars and interchangeable biosimilars. Applicants must notify the FDA of any changes in the product, manufacturing process, quality controls, equipment, facilities, or personnel specified in the approved Biologics Licence Application (BLA). These changes must be evaluated prior to sale or transport of the product through appropriate validation and/or clinical or non-clinical laboratory studies that the change will not adversely affect the identity, strength, quality, purity or potency of the product.

In general these FDA guidelines do not establish legally enforceable obligations. Instead, they describe the agency's current thinking on an issue and should be considered recommendations unless specific regulatory or legal requirements are cited.

The guidance applies to products approved as biosimilar or interchangeable under Section 351(k) of the Public Health Service Act. Section 351 provides an abbreviated approval pathway for products that are highly similar to an FDA-approved reference product without clinically meaningful differences in safety, purity, and potency. For interchangeability, it must be demonstrated that the biological product provides the same clinical outcome as the reference product and that there are no increased risks in terms of safety or efficacy with repeated use.

The FDA uses the question-and-answer format to make recommendations on the development of these products. This guidance is part of FDA's commitment under the Biosimilar User Fee Act (BsUFA) renegotiation to promote the development of safe and effective biosimilars. The full document "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products" can be found on the FDA website.

Support for future guideline development

 The FDA is seeking industry views and feedback on the following questions:

• What would be more useful to accelerate biosimilar development: guidance that focuses on a specific product or guidance that applies to an entire class of biosimilar products, such as monoclonal antibodies?
  
• Should the FDA focus on developing guidance for biologic products (or classes of biologic products) for which there are no approved biosimilars yet, or would it make sense to continue to develop guidance for these products or classes even after one or more biosimilars have been approved?

The FDA has established a dossier to receive information and comments to help the agency move forward with the development of new biosimilar biological products under the Biosimilar User Fee Amendments of 2022 (BsUFA III). The FDA wants to determine whether the development of biosimilars can best be promoted through focused guidelines for product classes or through the development of product-specific guidelines, similar to the approach of the Generic Drug User Fee Amendments (GDUFA) programme. You can comment on the "Biosimilar Product Development Guidance; Establishment of a Public Docket" on the Federal Register website until 23 October 2024.