On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and only interchangeable biosimilar to Novo Nordisk’s NOVOLOG (insulin aspart injection) in the United States. KIRSTY is…
On April 18, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the supplemental Biologics License Application for EYLEA HD (aflibercept). The supplemental application is for the addition of extended dosing intervals (up to every 24 weeks) of EYLEA HD injection…
GLOBAL BIOSIMILAR UPDATES Celltrion Bolsters Biosimilars Market Position in Italy Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle d’Aosta, Liguria, and Sardegna. Combined, these contracts…
On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen’s STELARA. STEQEYMA is approved for subcutaneous injection or intravenous infusion in adult and pediatric patients for treatment of various psoriatic conditions, Crohn’s disease, and ulcerative colitis. STEQEYMA is the seventh ustekinumab biosimilar…
On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ. Referencing Regeneron’s biosimilar product EYLEA, OPUVIZ is a 40 mg/mL solution for injection, approved for the treatment of neovascular age related macular degeneration, visual impairment due to macular oedema secondary to retinal…
On October 14, 2024, Accord BioPharma, Inc. announced that the FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to Johnson & Johnson’s STELARA (ustekinumab), indicated for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. IMULDOSA is Accord BioPharma’s second FDA-approved biosimilar product in the…
On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product” classification. See Eli Lilly & Co. v. Becerra et al., No. 1:24-cv-01503 (S.D. Ind.). Lilly argues…
On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”). The FDA specifically seeks…
On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine (“RSV”), mRESVIA (mRNA-1345). The vaccine was designed to protect adults from lower respiratory tract disease caused by an RSV infection. This is the second mRNA vaccine Moderna has developed to gain FDA approval, following…
On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics Evaluation and Research (“CBER”) and Center for Drug Evaluation and Research (“CDER”), was designed to “help further accelerate the development…