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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

Cytiva Introduces MabSelect SuRe 70 & PrismA X to Boost Cost-Efficient mAb Purification

MabSelect SuRe 70 and MabSelect PrismA X resins to set new standards in affordability and productivity Cytiva's expanded resin portfolio wil...

April 04, 2025 | News

Henlius and Organon’s HLX11 Biosimilar of Pertuzumab Accepted for Review by European Medicines Agency

Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Appli...

March 31, 2025 | News

Celltrion’s Biosimilar STEQEYMA® Added to Costco Member Prescription Program to Expand Access and Affordability

STEQEYMA® (ustekinumab-stba) is Celltrion's biosimilar to STELARA® (ustekinumab), which was launched on March 12, 2025 Celltrion'...

March 28, 2025 | News

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

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