Title VII of Biosimilars Price Competition and Innovation Act (BCPIA) of 2009 include provisions that require FDA to transition those drugs that are biologics in science and have been regulated under the FD&C Act to become biologics regulated under the PHS Act on 23rd March 2020 (10 years after enactment of BPCIA). These include a number of products, principally hormones. The transition product that will impact most patients are the insulins. FDA has determined that all of the “transition” (also called “rollover”) products will become standalone biologics regulated according to 351(a), and that none will become biosimilars under 351(k). This session will discuss the implications for stakeholders, especially patients, of this change.
Learning Objective : At the conclusion of this session, participants should be able to:
Describe the current environment in the US for the transition products and know which products are affected
Understand that the insulin products themselves will be unchanged even as their labels undergo minor revisions and that no insulin biosimilars will be available immediately
Be able to explain to patients, and their health care providers, FDA actions for the transition medicines
Eva Temkin, JD
Acting Director of Policy, Office of Therapeutic Biologics and Biosimilars, CDER