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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

South Korea’s Celltrion Secures U.S. FDA Approval to Expand AVTOZMA® IV for Cytokine Release Syndrome in Adults and Children

Approval of AVTOZMA® (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and pediatric patients aged 2 years an...

August 07, 2025 | News

Celltrion Launches STOBOCLO® and OSENVELT® Biosimilars in the U.S. for Comprehensive Bone Health and Oncology Care

STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and X...

July 08, 2025 | News

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

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

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