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…
On October 14, 2026, the U.S. District Court for the District of New Jersey entered an order dismissing without prejudice all claims in Genentech Inc. and Hoffmann-La Roche Inc.’s BPCIA litigation against Biocon Biologics Inc. concerning its proposed pertuzumab biosimilar. The same day, Biocon announced that it had entered into a…
On October 1, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) and Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced a new global license, development, and commercialization agreement for up to six potential biosimilar candidates. As with the companies’ previous collaborations, Samsung Bioepis will be responsible for development, regulatory registration, and manufacturing, while…