On February 9, 2012, FDA issued its long-awaited draft guidance on biosimilar product development. The agency issued a suite of three guidance documents that collectively address scientific considerations and quality considerations in demonstrating biosimilarity to a reference product and offer a Q&A on the Biologics Price Competition and Innovation Act of 2009 (BCPIA). The scientific considerations document emphasizes a risk-based approach based on the totality of the evidence and recommends a “stepwise” approach to developing biosimilars. The quality considerations document, applicable to reference protein products, gives an overview of analytical factors to consider in assessing the biosimilarity of a therapeutic protein product. The third, as its name indicates, is meant to answer common questions. The documents area meant to help industry in developing generic equivalents to brand-name biologic drugs and have been anticipated since BCPIA was enacted as part of health care reform in March 2010. FDA has also updated its Biosimilars web page to include the draft guidance document and a February 15theducational webinar and presentation slides where the agency provided participants with an overview of the law, the FDA’s progress in implementation, and updates on next steps.
24 Feb '12