On October 2, 2025, Celltrion, Inc. (“Celltrion”) announced the commercial launch of AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® in the United States. AVTOZMA® is supplied as an intravenous formulation in single-dose vials in the same doses as ACTEMRA®: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL. It is…
On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however, there are a number of district court actions against other parties related to the patents challenged in Fresenius’s IPRs….
On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates. The applications for the two candidates, biosimilars to Amgen’s PROLIA (denosumab) and XGEVA (denosumab), respectively, cover “all indications covered by the reference…
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively. These approvals make Fresenius the fourth company to receive FDA approval for a pair of denosumab biosimilars, joining Celltrion, Samsung, and Sandoz. Denosumab is a RANK ligand (RANKL)…
On December 1, 2024, Biocon announced that the FDA has approved YESINTEK™ (ustekinumab-kfce), a biosimilar to J&J’s STELARA®. YESINTEK is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. According to the announcement, Biocon had entered into a settlement and licensing agreement with Janssen to…
On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab). The BLA includes both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. This is the first BLA accepted by FDA for a tocilizumab biosimilar. …
Last week, the PTAB instituted inter partes review of two Chugai patents directed to methods of treating rheumatoid arthritis with a combination of tocilizumab and methotrexate. Fresenius filed petitions for inter partes review on U.S. Patent Nos. 7,521,052 (“the ’052 patent”) and 10,744,201 (“the ’201 patent”) on June 28, 2021. …
Below are some highlights of recent biosimilar development news from this week: On September 20, Mochida announced that it had obtained marketing approval in Japan for RGB-10, a biosimilar of FORTEO (teraparitide) that Mochida developed in Japan based on a comprehensive license and collaboration agreement with Gedeon Richter Plc. Mochida…