On January 12, 2026, Sanofi announced that the European Commission approved its Teizeild (teplizumab) for delaying progression to stage 3 type 1 diabetes (“T1D”) in adults and children eight years and older who have stage 2 T1D. Teizeild marks the first disease-modifying treatment for T1D available in the EU. Sanofi…
On November 27, 2025, Celltrion announced that Health Canada approved EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron’s EYLEA® (aflibercept), in both vial and pre-filled syringe form, to treat all indications approved for EYLEA®. EYDENZELT® is Celltrion’s first biologic product approved in Canada in the ophthalmology space. According to media reports, Celltrion…
On December 1, 2025, Sun Pharmaceutical Industries Ltd. (“Sun Pharma”) announced the launch of ILUMYA® (tildrakizumab-asmn) in India. ILUMYA® is a humanized monoclonal antibody injection indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Dr. B. S. Chandrashekar, Chief Dermatologist and Managing…
Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord. On December 1, 2025: Sandoz launched its denosumab biosimilars, WYOST (120 mg) and JUBBONTI (60 mg) in Europe. WYOST is approved for the treatment of…
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 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. Under the agreement, Lupin will lead development, manufacturing, and supply of the biosimilar. Zentiva will handle commercialization in the Europe and CIS markets, leveraging…
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria. The study met both primary and secondary endpoints, demonstrating therapeutic equivalence and comparable safety to the reference product. ADL-018, developed…
On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the U.S. launch of EPYSQLI® (eculizumab-aagh), a biosimilar referencing Alexion Pharmaceuticals’ SOLIRIS®. As we reported in January, Teva and Samsung Bioepis entered into a strategic partnership regarding EPYSQLI®, with Samsung Bioepis handling development, manufacturing, and supply and Teva…
On March 12, 2025, Celltrion announced the commercial launch of STEQEYMA® (ustekinumab-stba), a biosimilar of Janssen’s STELARA® (ustekinumab), in the United States. As we previously reported, the biosimilar was approved by the FDA in December 2024 for subcutaneous injection or intravenous infusion in adult and pediatric patients for treatment of…
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizations for three biosimilar products—Amgen’s PAVBLU and SKOJOY, and CuraTeQ Biologics’ DYRUPEG. Amgen’s PAVBLU and SKOJOY, both biosimilars referencing EYLEA…