On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA. Both OSVYRTI® and JUBEREQ® are approved for all indications of their respective reference products. Denosumab is a…
On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”) resolving the BPCIA litigation regarding Accord’s denosumab biosimilar, INTP23. Pursuant to the agreement, Accord will be…
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…