FDA recently released a set of 3 draft guidance documents related to the development of biosimilar products—a biological product (vaccine, protein, tissue, blood or blood component, gene therapy, etc.) that is highly similar to a reference product previously approved by FDA.  The new guidance addresses many of the common questions of those developing biologics and biosimilars, and it promises to open new doors for the application and delivery of approved biosimilar products.

Most significantly, the new guidance provides for approved biosimilars to be paired with alternative delivery devices, in addition to any devices approved for the reference biological product.  This is part of FDA’s effort to increase competition among biosimilar products and developers, and ensure “better patient access and lower cost to consumers,” according to Janet Woodcock, MD, director of FDA Center for Drug Evaluation and Research (CDER). (be sure to source this quote)

Biosimilars may be approved through an abbreviated regulatory pathway under section 351(k) of the 2010 Patient Protection and Affordable Care Act by submitting a “351(k) application”.  For more information or to read the new guidance, click here.  Pearl Pathways has a strong capability in biologics product development and staff with extensive experience in large molecule regulatory submissions.   Need help with developing or implementing a biosimilar regulatory filing?  Send us an email at contact@pearlpathways.com.