As mentioned in a previous post, the EMA set the standard for regulatory approval of biosimilars* with the adoption of their overarching general guideline in 2005 (CHMP/437/04 — PDF), followed shortly thereafter by guidelines on quality issues (EMEA/CHMP/BWP/49348/2005 — PDF) and on non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005 — PDF). The pathway for biosimilar approval was further delineated by the issuance of a number of product-class specific guidances, e.g., for epoetins and somatropins.
After more than five years of experience reviewing, approving and regulating biosimilars, the EMA has recently issued concept papers that articulate contemplated changes in the general biosimilars guidelines. While some may view these as a loosening of standards, others may view these contemplated changes as a refinement of the pathway. Either way, Europe’s experience with biosimilars is likely to color the U.S. Food and Drug Administration’s (FDA) implementation of the U.S. biosimilar pathway enacted in the Biologics Price Competition and Innovation Act of 2009 (PDF). FDA expects to issue initial guidance soon.
The comment period for the EMA concept paper on the revision of guidelines for biosimilars’ non-clinical and clinical issues (PDF) was open until December 31, 2011; the comment period for the concept paper on the revision of the general guidelines (PDF) is open until February 29, 2012. Draft revised guidelines are expected to be issued by the EMA in the first half of 2012.
*Called “similar biological medicinal products” under E.U. law (Directive 2001/83/EC)