by April Breyer Menon | Dec 19, 2023
On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). There is currently another pending aBLA for a...
by April Breyer Menon | Dec 15, 2023
There has been a flurry of activity relating to proposed EYLEA® (aflibercept) biosimilars in November, starting with a BPCIA litigation against Celltrion’s proposed biosimilar CT-P42 filed on November 8, 2023, Case No. 1:23-cv-00089 (N.D.W.Va.) (see BPCIA Litigation...
by April Breyer Menon | Dec 13, 2023
On November 17, 2023, Genentech, Inc., Hoffmann-La Roche Inc., and Biogen Inc. (“Plaintiffs”) filed a BPCIA complaint (“Complaint”) against Dr. Reddy’s Laboratories, Inc., Dr. Reddy’s Laboratories SA (“DRL SA”), Dr. Reddy’s Laboratories Ltd., Fresenius Kabi USA, LLC,...
by April Breyer Menon | Dec 8, 2023
On November 22, 2023, Biocon Biologics Inc. (“Biocon”) submitted a Petition for Inter Partes Review of claims 1-34 of U.S. Patent No. 10,961,307 (“the ’307 patent”), assigned to Janssen Biotech, Inc. (“Janssen”), requesting that trial be instituted and the challenged...
by April Breyer Menon | Nov 22, 2023
On November 8, 2023, Regeneron Pharmaceuticals Inc. filed a BPCIA Complaint against Celltrion Inc. in the district court for the northern district of West Virginia, asking the Court to block CT-P42 – Celltrion’s proposed biosimilar of Regeneron’s drug...
by April Breyer Menon | Nov 5, 2023
On October 31, 2023, the FDA approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab). In May 2023, Amgen and Janssen settled their BPCIA lawsuit, with an agreement...