Charles River Biopharmaceutical Services (BPS) wants to keep you up-to-date on the changing regulatory environment of our industry. This page will include summaries and links to relevant regulatory documents that are either under discussion or recently published.
EU Indicates Acceptance of Non-EU Reference Products for Biosimilars
The current guidelines for biosimilar product registration in Europe require the use of a reference product that has been approved in Europe. Draft guidance issued on 02 May 2013 indicates a change in this stance as regulators around the world recognize the cost and ethical issues in conducting multiple clinical trials with different reference products to satisfy each regulatory area. Provided the reference product has been authorized by “a regulatory authority with similar scientific and regulatory standards as EMA”, and bridging analytical studies with the biosimilar, the EU reference product and the non-EU reference product are successfully conducted, this paves the way for a single set of preclinical and clinical trials for the global registration of a biosimilar product.
The draft guideline is open for comments until 31 October 2013.
On February 9, 2012, almost 3 years after the Biologics Price Competition and Innovation Act (BPCIA) of 2009 amended section 351(k) of the Public Health Service (PHS) Act to create a legal pathway for biosimilars in the US, the FDA published the series of draft guidance documents listed below to define their recommendations for biosimilars development. These draft documents are open for comment for 60 days from the publication date. The final documents are likely to differ from the drafts.
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009