Welcome to our 1Q 2020 update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics.
Notably, the BPCIA celebrated its 10-year anniversary on March 23, 2020. During the time it has been in force, 26 biosimilars have been approved 16, of which have launched despite the call for legislative/regulatory fixes to increase competition. Strikingly, the number of post-grant challenges against biologics patents has precipitously dropped since reaching a peak in 2017, marking a shift to challenges in district court.
Additionally, on this anniversary of the BPCIA, applications for insulins are now deemed to be a license for the product under the Public Health Service (PHS) Act. This will, for the first time, enable submission of applications for products that are proposed as biosimilar to these insulins.
Please see full publication below for more information.