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Celltrion Launches STEQEYMA®, a Biosimilar to STELARA®, in the U.S. at an 85% Lower WAC List Price

STEQEYMA®, one of the first-wave biosimilars to STELARA®, is now available in the U.S. Approved for the same indications as the reference produc...

March 13, 2025 | News

Celltrion’s OMLYCLO® Becomes First FDA-Approved Interchangeable Biosimilar to XOLAIR®

OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for intercha...

March 10, 2025 | News

Celltrion Secures FDA Approval for STOBOCLO® and OSENVELT® as Biosimilars to PROLIA® and XGEVA®

STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA®&nbs...

March 05, 2025 | News

SmithRx Expands Connect 360 Autoimmune Program Adding Stelara Biosimilars and Partnering with Costco Specialty Pharmacy

SmithRx, a transparent, 100% pass-through modern pharmacy benefits manager (PBM), announced a major expansion to its Connect 360 Autoimmune Program, ...

March 03, 2025 | News

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

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