BioPharma BioSimilar
South Korea’s Celltrion Secures EU Approval for Three Biosimilar Products, Expanding Its Portfolio to 11 by 2025
Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt® (aflibe...
February 19, 2025 | News
Henlius and Dr. Reddy’s Forge Licensing Deal for Daratumumab Biosimilar in U.S. and Europe
Shanghai Henlius Biotech, Inc. announced it has entered into a license agreement with Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Redd...
February 07, 2025 | News
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
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