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rBIO’s Biosimilar Insulin, R-biolin, Matches Novolin® R in Preclinical Studies; Company Moves Towards 50x Scale-Up and Human Trials

rBIO's biosimilar insulin, R-biolin, achieves bioequivalence to Novo Nordisk Novolin® R in animal studies; company prepares for 50x scale-up and readie...

February 05, 2025 | News

Celltrion Secures FDA Approval for AVTOZMA® Biosimilar to ACTEMRA® in IV and SC Formulations

AVTOZMA® will be available as both intravenous (IV) and subcutaneous (SC) formulations with the same formulations and dosages as the reference p...

January 31, 2025 | News

Taiwan’s Taikang Biotech Joins Forces with Mitsubishi Gas Chemical and Taiwan Sugar Alliance to Propel SPD8 Biosimilar Globally

Taikang Biotech (6589), Mitsubishi Gas Chemical Co., Ltd. (MGC), and the Taiwan Sugar Association (4168) have entered into a strategic tripartite agreement...

December 26, 2024 | News

CHMP Endorses Celltrion’s Biosimilars Eydenzelt Stoboclo Osenvelt and Avtozma for Expanded Access to Biologic Treatments

The Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenz...

December 16, 2024 | News

Bio Usawa and Rwanda Development Board Partner to Launch First Eye Treatment Manufacturing Plant in Rwanda

Bio Usawa and the Rwanda Development Board have partnered to establish Rwanda’s first manufacturing plant for affordable treatments for serious eye...

November 22, 2024 | News

South Korea’s Celltrion Acquires iQone Healthcare Switzerland to Boost Direct Commercialization of Biosimilars in Europe

Celltrion announces acquisition of iQone Healthcare Switzerland, accelerating direct commercialization of its biosimilars in the European region T...

November 18, 2024 | News

Taiwan’s Formosa Pharmaceuticals Partners with Portugal’s DÁVI Farmacêutica to Introduce APP13007 for Post-Surgical Ocular Pain Relief in Europe

Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with DÁVI Far...

November 01, 2024 | News

Biocon Biologics Secures Market Access for Bmab 1200 in Europe, UK, Canada, and Japan Through Janssen Settlement

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd , announced that the Company has signed a settleme...

August 29, 2024 | News

GCCL Launches R&D Division to Bolster Biosimilar and Clinical Trial Analysis Services

Newly established R&D division this year is expected to provide full-scale in-house R&D in addition to clinical sample analysis Including blockb...

July 17, 2024 | News

Alteogen Subsidiary Altos Biologics Submits MAA to EMA for ALT-L9 Aflibercept Biosimilar

Alteogen Inc. announced that its subsidiary, Altos Biologics Inc. has submitted Marketing Authorization Application (MAA) to the European Medicines Ag...

July 02, 2024 | News

FDA Approves Bkemv as First Interchangeable Biosimilar to Soliris

U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare di...

May 29, 2024 | News

Henlius Biotech and Organon Receive EMA Validation for Denosumab Biosimilar HLX14

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing autho...

May 27, 2024 | News

Teva Pharmaceuticals and mAbxience Forge Global Strategic Partnership for Oncology Biosimilar Development

Teva and mAbxience enter into a strategic global partnership for in-licensing of an oncology biosimilar candidate Agreement signals a major step i...

April 05, 2024 | News

Biocon Biologics Teams Up with Sandoz Australia for Biosimilar Trastuzumab and Bevacizumab

Under the agreement, Sandoz will distribute the Biocon Biologics' brands, OGIVRI® (bTrastuzumab) and ABEVMY® (bBevacizumab), and facilita...

February 09, 2024 | News

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