On November 3, 2026, Teva announced that it had entered into a licensing agreement with Samsung Bioepis to commercialize RENFLEXIS® (infliximab-abda), a biosimilar to Johnson & Johnson’s REMICADE® (infliximab), and ETICOVO® (etanercept-ykro), a biosimilar to Amgen’s ENBREL® (etanercept). Infliximab is a tumor necrosis factor (TNF) inhibitor used for the treatment…
On November 2, 2026, Fresenius announced that it had entered into an exclusive development agreement with WuXi Biologics for the research, development, and manufacturing of biosimilars. The agreement provides Fresenius with exclusive access to up to 37 identified biosimilar candidates spanning 13 therapeutic areas, including neurology, nephrology, cardiopulmonary, oncology, immunology,…
On November 2, 2026, Theriva Biologics, Inc. (“Theriva”) announced the sale of its portfolio of antibiotic-degrading enzymes to Biossil Labs Inc. (“Biossil”), a privately held, Toronto-based, AI-native biopharmaceutical company. Biossil acquired all of Theriva’s rights, title, and interest in SYN-004 (ribaxamase) and its improvements, modifications, and reformulations, including SYN-007 (reformulated…
Adalvo announced on October 27, 2026 that it acquired Enzene’s romiplostim biosimilar program. The program references Amgen’s NPLATE®, which is indicated to treat adult and chronic pediatric immune thrombocytopenia (ITP). Romiplostim, a Fc-peptide fusion protein (peptibody), is a thrombopoietin receptor agonist (TPO-RA). The acquisition combines Adalvo’s global development, regulatory and…
On October 29, 2026, Xbrane Biopharma announced that the FDA approved LUCAMZI™ (ranibizumab-blrz), a biosimilar to LUCENTIS® (ranibizumab). Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy used to treat retinal vascular disorders, including neovascular (wet) age-related macular degeneration. According to Xbrane, the approval was supported by comparative structural and…
On October 26, 2026, Bio-Thera Solutions announced that China’s National Medical Products Administration (“NMPA”) approved BAT2306, its biosimilar to COSENTYX® (secukinumab). BAT2306 will be marketed as YOUZHUOMEI® and is approved for psoriasis, ankylosing spondylitis, and psoriatic arthritis. According to Bio-Thera, BAT2306 is the first secukinumab biosimilar approved in China. Bio-Thera…
On October 14, 2026, Armed Cell Therapeutics BV (“Armed Cell”) announced that it acquired a portfolio of preclinical CAR-T assets from Lakefront Biotherapeutics NV (“Lakefront”), formerly Galapagos NV. The two lead programs focus on non-Hodgkin lymphoma and small cell lung cancer. Under the agreement, Lakefront receives an upfront payment and…
On October 13, 2026, the European Union’s (EU) European Commission made Sanofi’s commitments not to disparage a competing flu vaccine legally binding. The Commission found that Sanofi’s enhanced flu vaccine in the EU, Efluelda, competes with the EU’s only other enhanced flu vaccine, CSL Seqirus’s Fluad. From 2024 through fall…
On October 14, 2026, Alvotech and Advanz Pharma announced the submission of a European regulatory application for AVT29, a proposed biosimilar to Eylea® 8 mg (aflibercept 114.3 mg/mL), marketed as Eylea HD® in the United States. This is the first publicly announced regulatory submission worldwide for a proposed biosimilar to…
On October 13, 2026, Formycon and Zydus announced that the FDA accepted for review the Biologics License Application for FYB206, a proposed biosimilar to Merck’s KEYTRUDA® (pembrolizumab). This is the first publicly announced FDA acceptance of an application for a proposed KEYTRUDA® biosimilar. Formycon also submitted the regulatory dossier to…