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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

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

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