Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates. The two candidates, VEVZUO and Denosumab BBL (the brand name is currently under approval), are each intended for distinct therapeutic indications. According…
On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the treatment of certain types of osteoporosis and bone loss. JUBEREQ is indicated for the prevention of certain…
On November 13, 2024, Amgen filed a BPCIA complaint in the District Court for the Eastern District of North Carolina against Accord Biopharma, Inc.; Accord Healthcare, Inc.; and Intas Pharmaceuticals, Ltd., related to Accord’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the fifth BPCIA litigation regarding denosumab, following Amgen’s litigations…
On July 14, Dong-A ST announced that the European Medicines Agency accepted its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar referencing STELARA (ustekinumab). STELARA is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The MAA submission was based on the results of a…
On November 14, 2019, the parties in the Amgen v. Accord (previously Apotex) follow-on BPCIA litigation filed a Stipulation of Dismissal, agreeing “to the dismissal, without prejudice, of all remaining claims and counterclaims in this action with the parties to bear their own costs and attorney’s fees.” The next day,…
As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the district court on August 8 that they were drafting a stipulation and unopposed motion that would substitute Apotex as a party with a then-unnamed…