Topic
Biosimilars
850 published works
Big Molecule Watch
STADA and SBP Group Launch Biosimilars Partnership
STADA and Sino Biopharmaceutical Limited (“SBP Group”), through its subsidiary Chia Tai Tianqing Pharmaceutical Group (“CTTQ”), have entered into a partnership to manufacture, market, and sell biosimilars. CTTQ will develop,…
Big Molecule Watch
USPTO Institutes Four IPRs Challenging Janssen’s Golimumab Method-of-Treatment Patents
By Grace Truong
On September 9, 2026, the U.S. Patent and Trademark Office issued a Notice of Decisions on Institution granting institution in four inter partes review proceedings challenging Janssen Biotech, Inc.’s golimumab…
Big Molecule Watch
BMS and Ono File BPCIA Suit Against Amgen for Nivolumab Biosimilar
By Alice Yoon
On September 8, 2026, Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., (collectively, “BMS”) and Ono Pharmaceutical Co., Ltd. (“Ono”) filed a BPCIA complaint in the U.S. District Court…
Big Molecule Watch
Cipla and Qilu Announce Exclusive U.S. Licensing and Supply Agreement for Pembrolizumab Biosimilar
By Sam Herron
On September 3, 2026, InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, announced a strategic partnership and exclusive license with Qilu Pharmaceutical Co., Ltd. for the licensing and…
Big Molecule Watch
Biocon Enters Ten-Year Pertuzumab Supply Contract in Brazil
On September 8, Biocon Limited (“Biocon”) announced that, in partnership with Bahiafarma, a Brazilian public pharmaceutical laboratory, and Bionovis, a Brazilian biotechnology company, it had secured a ten-year contract to…
Big Molecule Watch
Takeda Files BPCIA Suit Against Alvotech for Vedolizumab Biosimilar
By Emma Murray
On September 1, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey…
Big Molecule Watch
Alvotech and Lotus Enter Agreement for Durvalumab and Emicizumab Biosimilars
By Yoko Bian
On August 21, 2026, Alvotech announced a licensing and commercialization agreement with Lotus Pharmaceutical (“Lotus”) for AVT34, a proposed biosimilar to IMFINZI® (durvalumab), and AVT87, a proposed biosimilar to HEMLIBRA®…
Big Molecule Watch
Biocon Announces Supplemental U.S. FDA Approval for Prefilled Autoinjector for YESINTEK
On August 18, 2026, Biocon Ltd. (“Biocon”) announced that its U.S. subsidiary has received supplemental U.S. FDA approval for YESINTEK® (ustekinumab-kfce) in a single-dose prefilled autoinjector, 45 mg/0.5 mL and…
Big Molecule Watch
Takeda Files BPCIA Suit Against Polpharma Biologics For Vedolizumab Biosimilar
On August 26, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey…
Big Molecule Watch
Biocon Launches Aflibercept Biosimilar in the United States
On August 3, 2026, Biocon Limited announced the commercial launch of its biosimilar YESAFILI (aflibercept-jbvf) in the United States. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor that is…