Current Edition

After a Slow Start, US Biosimilar Approvals Accelerated in 2018

The US Food and Drug Administration (FDA) has approved eight biosimilars since May 2018 – seven in 2018 and one more in January 2019 – nearly doubling the number approved since the Biologics Price Competition and Innovation (BPCI) Act of 2009 introduced an abbreviated approval pathway uniquely for them. Meg Egan Auderset of Clarivate looks at these recent US Biosimilar approvals, as well as the FDA guidance documents related to biosimilars.