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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
FDA Approves Henlius and Organon’s Denosumab Biosimilars BILDYOS and BILPREVDA for All US Indications
Shanghai Henlius Biotech, Inc. and Organon announced that the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) inject...
September 04, 2025 | News
Abbott Secures Thailand Approval For Denosumab Biosimilar Expanding Access To Osteoporosis Treatment
Abbott denosumab biosimilar has received regulatory approval in Thailand, expanding access to advanced therapies for osteoporosis and cancer-related bone l...
August 27, 2025 | News
China’s Bio-Thera and Europe’s STADA Expand Biosimilars Alliance to Include Tocilizumab
Bio-Thera and STADA agree to extend their biosimilars alliance to cover tocilizumab, a targeted immunomodulatory monoclonal antibody directed against the...
August 25, 2025 | News
South Korea’s Celltrion Secures U.S. FDA Approval to Expand AVTOZMA® IV for Cytokine Release Syndrome in Adults and Children
Approval of AVTOZMA® (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and pediatric patients aged 2 years an...
August 07, 2025 | News
Celltrion Launches STOBOCLO® and OSENVELT® Biosimilars in the U.S. for Comprehensive Bone Health and Oncology Care
STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and X...
July 08, 2025 | News
Samsung Bioepis Partners with NIPRO to Expand Biosimilar Access in Japan
Samsung Bioepis expands its presence in Japanese market through partnership with NIPRO Corporation Marks a step forward in widening treatments options a...
June 09, 2025 | News
Celltrion’s YUFLYMA® Wins Expanded Interchangeability Status for All Humira® Dosage Forms in the U.S.
YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] Cellt...
May 26, 2025 | News
Celltrion’s YUFLYMA® Granted Full FDA Interchangeability with Humira® Across All Dosage Forms
YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] Cellt...
May 22, 2025 | News
Henlius Licenses Ipilimumab Biosimilar HLX13 to Sandoz in $301M Global Deal
Partnership covers North America, Europe, Japan, and Australia to accelerate global access of HLX13 in immuno-oncology combinations Henlius to receive $...
April 30, 2025 | News
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