(424c) Risk Based Roadmap for the Approval of Biosimilar Biologics

The development of biologics has grown significantly in recent years, due in part to the profitability for innovator companies, which currently enjoy exclusivity in the absence of ?generic? biologics. In the U.S. There is currently no guideline in place for the approval of ?biosimilar? biologics. With the rapid growth of biologics production and several biopharmaceutical patents nearing their expiration dates, a regulatory system is needed to classify ?biosimilar? biologics in order to allow abbreviated FDA approval whenever possible. A risk based classification system has the potential to allow for a more streamlined, cost-effective approach for assessing biosimilarity and safety, which could lead to more affordable biologics for patients. We have proposed a new risk based Classification System for Biologics (CSB) to establish biosimilarity based on risk assessment and level of characterization of the product. Immunogenicity and stability testing will be required for determining the possibility of a biowaiver with or without additional clinical testing.