Last week, Takeda announced that it has entered into a worldwide license and collaboration agreement (outside of Greater China) with Innovent Biologics for the development, manufacture, and commercialization of two late-stage oncology medicines, IBI363 and IBI343. According to Takeda, IBI363, a PD-1/IL-2α-bias bispecific antibody fusion protein, is being evaluated in…
On October 20, 2025, Teva Pharmaceuticals International GmbH (“Teva”) announced a licensing agreement with Prestige BioPharma Ltd. (“Prestige BioPharma”) to commercialize TUZNUE® (trastuzumab), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), in a majority of European countries. Under the license and supply agreement, Teva obtained the rights to market and distribute TUZNUE®…
On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. MYNZEPLI® will be available as a 40 mg/mL solution in a pre-filled syringe and vial and is approved for the same adult indications as…
On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass…
On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimilar FYB202/Fymskina (ustekinumab) in Germany. Under the terms of the distribution agreement, Formycon will be responsible for the manufacture and supply of FYB202/Fymskina and will…
On July 17, 2025, Harrow, Inc. (“Harrow”), announced an agreement with Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) to acquire the U.S. commercial rights to two of Samsung Bioepis’s biosimilars, BYOOVIZ® (ranibizumab-nuna) and OPUVIZ™ (aflibercept-yszy). Harrow is a North American pharmaceutical company that specializes in ophthalmologic products including topical antibiotic/corticosteroid combinations,…
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 June 12, 2025, BioNTech SE (“BioNTech”) announced its entry into a definitive purchase agreement to acquire all shares of CureVac N.V. (“CureVac”), with an implied aggregate equity value for CureVac of approximately $1.25 billion. The acquisition “aims to strengthen the research, development, manufacturing, and commercialization of [BioNTech’s] investigational mRNA-based…
On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s HLX15 (daratumumab), a biosimilar candidate to Janssen’s Darzalex® & Darzalex Faspro®. HLX15 (daratumumab) is a recombinant anti-CD38 fully…