On November 26, 2010, the European Medicines Agency (EMA) published a draft guideline (Guideline) for biosimilars for monoclonal antibodies (mAbs), a major product class of biotechnology-derived medicinal products. The work of the EMA’s Committee for Medicinal Products for Human Use (CHMP), the Guideline is entitled “Similar Biological Medicinal Products Containing Monoclonal Antibodies” and is being published for public consultation. The Guideline recommends a risk-based approach to evaluate mAbs on a case-by-case basis: “non-clinical studies should be performed before initiating clinical development. In vitro studies should be conducted first and a decision then made as to the extent of what, if any, in vivo work will be required.” Two additional key elements of the Guideline are these:
  1. “the focus of the biosimilarity exercise is to demonstrate similar efficacy and safety compared to the reference product”, and
  2. “extrapolation of clinical efficacy and safety data to other indications of the reference mAb, not specifically studied during the clinical development of the biosimilar mAb, is possible based on the results of the overall evidence provided from the biosimilarity exercise and with adequate justification.”
The draft Guideline is open for consultation until the end of May, 2011. The CHMP also released a related guideline (for consultation until the same date) on the immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. Follow this link for the full text of the Guideline. For Canada’s Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), follow the link in E-TIPS®, Vol 8, No 19, March 24, 2010 (”Health Canada Releases Finalized Guidance on Subsequent Entry Biologics”). Summary by: Clare McCurley

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