In the August 4 New England Journal of Medicine (NEJM), four high-level FDA officials authored an article that outlines FDA’s progress in developing the biosimilars approval standards, which FDA expects to issue later this year under the Biologics Price Competition and Innovation Act (BPCIA), which was passed as a part of the larger health care reform bill. In “Developing the Nation’s Biosimilars Program,” Dr. Steven Kozlowski (Director, Office of Biotechnology Products), Dr. Janet Woodcock (Director, Center for Drug Evaluation and Research), Dr. Karen Midthun (Director, Center for Biologics Evaluation and Research) and Dr. Rachel Behrman Sherman (Associate Director for Medical Policy) highlight that an entirely new framework will be required for evaluating biosimilars, one that requires much more data and analysis than the approval process for traditional generic drugs.
The article indicates that FDA is evaluating the biosimilars guidelines adopted by the European Medicines Agency (EMA) in 2005 and 2010, and that FDA will most likely adopt EMA’s product-specific approach, which creates different standards for different product categories. Additionally, FDA may allow “fingerprint” technology—which allows biosimilar drugs to be more easily compared to the reference biologic product—to substitute for full-scale clinical trials in some cases, depending on whether the mechanism of the biologic drug is well characterized. A Patent Docs article provides a more detailed summary of the NEJM article.