FDA finalizes Guidelines for Biosimilars

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

In February 2009, the US Food and Drug Administration has published three draft guidance documents on the development of biosimilars. Now, on 15 April, the FDA issued the finalized version of these three documents:

1. "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product" - provides guidance to companies which must demonstrate the boisimilarity of a therapeutic protein product to an existing reference product. The guidance recommends a stepwise risk-based "totality-of-the-evidence" approach to evaluate the biosimilarity to the reference product relating to structure, function, animal toxicity pharmacokinetics and pharmacodynamics, clinical immunogenicity, and clinical safety and effectiveness.

2. "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product" - This document comprises information about analytical factors and the importance of extensive analytical, physico-chemical and biological characterisation of a Biosimilar. These factors are unalienable to demonstrate high similarity to a reference product.

3."Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 - This guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The document  classifies the Q&As in three different groups, relating to their content:

• Biosimilarity or Interchangeability
• Provisions Related to Requirement to Submit a BLA for a "Biological Product"
• Exclusivity

These documents should  assist industry in developing such biosimilar products in the United States and provide the FDA’s current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products to the agency. Through this approval pathway, biological products are approved based on demonstrating that they are biosimilar to / or interchangeable with a biological product that has already been approved by the FDA, which is called a reference product.

These three documents are part of FDAs guidance series developed to implement the BPCI Act (Implementation of the Biologics Price Competition and Innovation Act of 2009). This series includes amongst the three ´guidance documents the guidelines for

• Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

The intention of these documents is to meet the demands of the requirements of Patient Protection and Affordable Care Act. They should establish a shorter and faster way for approval for Biosimilars under section 351(k).