Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics.

Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), 40 biosimilars have been approved, 22 of which have launched. Notably, since our last update, the first BPCIA complaint was filed for Eylea with Regeneron accusing Mylan of infringing 24 patents. Strikingly, the number of post-grant challenges against biologics patents has precipitously dropped since reaching a peak in 2017. In legislative developments, Sen. Mike Lee (R-UT) introduced draft legislation titled the “Biosimilar Red Tape Elimination Act,” which would stop the FDA from requiring biosimilars to conduct ‘unnecessary’ switching studies in order to obtain an interchangeability designation.

We hope you find this update informative.