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 BPCIA, 29 biosimilars have been approved, 16 of which have launched.
Strikingly, the number of post-grant challenges against biologics patents has precipitously dropped since reaching a peak in 2017.
On the legislative front, two members of the House of Representatives proposed a bill designed to decrease drug costs by increasing the reimbursement to hospitals and doctors for biosimilar drugs. Additionally, the Biden-Harris administration recently introduced a series of executive orders meant to promote generic drug and biosimilar competition with the specific goal of making approvals of those copycat medicines “more transparent, efficient, and predictable.”
Please see full publication below for more information.