BioSimilar
Celltrion Secures Positive CHMP Opinion For SteQeyma Autoinjector In Europe
SteQeyma™ 45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcu...
December 19, 2025 | News
Innovent Biologics Seven Innovative Therapies Included in China’s 2025 National Reimbursement Drug List
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high qual...
December 08, 2025 | News
Samsung Bioepis Gains CHMP Backing for BYOOVIZ Pre Filled Syringe
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for BYOOVIZ® (ranibizuma...
December 03, 2025 | News
Celltrion Gains EU Approval for Omlyclo 300 mg Prefilled Syringe as First Omalizumab Biosimilar
Omlyclo™ (omalizumab) is the first and only omalizumab biosimilar approved in Europe Omlyclo™ 300 mg/2ml prefilled syringe (PFS) presentat...
November 19, 2025 | News
Shanghai Henlius and Organon Achieve FDA Approval for POHERDY, First Pertuzumab Biosimilar in the US
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has approved the Biologics...
November 19, 2025 | News
EirGenix and Sandoz Sign USD 152 Million Global Deal for Pertuzumab Biosimilar
EirGenix Inc. announced that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQ...
November 13, 2025 | News
Samsung Bioepis Reaches Settlement with J&J on Stelara Biosimilar PYZCHIVA in Europe
Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson concerning the commercialization of PYZCHIVA®, a bio...
November 07, 2025 | News
Samsung Epis Holdings Established as New Biotechnology Investment Holding Company Following Spin-Off from Samsung Biologics
Samsung Epis Holdings Co., Ltd.announced its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Sa...
November 04, 2025 | News
Celltrion Receives U.S. FDA Interchangeability Designation for Denosumab Biosimilars STOBOCLO® and OSENVELT®
The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the ref...
November 03, 2025 | News
Celltrion Receives FDA Approval for EYDENZELT®, a Biosimilar to EYLEA® for Retinal Diseases
EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following ret...
October 13, 2025 | News
Celltrion Launches AVTOZMA IV FDA Approved Tocilizumab Biosimilar in United States
The AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as t...
October 03, 2025 | News
Polpharma Biologics Restructures into Two Companies: Biosimilars and Rezon Bio CDMO
Polpharma Biologics announced a strategic corporate transformation, demerging into two independent companies to strengthen focus and accelerate growth acro...
September 30, 2025 | News
Henlius and Organon Secure EC Approvals for Denosumab Biosimilars BILDYOS® and BILPREVDA®
Shanghai Henlius Biotech, Inc., and Organon announced the European Commission (EC) has granted marketing authorization for BILDYOS® (de...
September 22, 2025 | News
EC Approves Alteogen’s EYLUXVI® as Eylea® Biosimilar for Major Ophthalmic Indications
EYLUXVI® is the second biosimilar approved for Alteogen following the launch of the Herceptin® biosimilar in China through it...
September 18, 2025 | News
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