FDA - New draft guidances for Biosimilars

On 9 February the US Food and Drug Administration published three draft guidance documents on the development of biosimilar products.

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 a existing reference product. The guidance recommended 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 highly 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

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).

Please pay attention to the ECA 8th Bio Production Forum from 19-21 June 2012. Among the main topics of the conference 2012 are the regulatory and scientific requirements with regard to Biosimilars.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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