Celltrion’s Biosimilar Rituximab Brings Indication Carve Outs To US FDA Panel Review
Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.
You may also be interested in...
Amgen and Allergan’s launch of the first biosimilars to Roche/Genentech’s Avastin and Herceptin may not face the same commercial dynamics that have stymied biosimilars in other therapeutic areas, but uptake could depend upon oncologists’ comfort level in prescribing the follow-on agents.
Expect plenty of litigation over what constitutes infringement of a method-of-use patent even when the protected indication is not found on a biosimilar’s labeling, a panel of legal experts said at the recent BIO meeting; another area of unsettled law is the extent to which a biosimilar sponsor has satisfied the information-exchange provisions of the BPCIA ‘patent dance.’
Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.