Business Wire

Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA ® Biosimilar HADLIMA ™ (adalimumab-bwwd)

INCHEON, Korea & JERSEY CITY, N.J.--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, ...
Monthly Prescribing Reference

Anti-TNF Biosimilar Hadlima Receives FDA Approval

The Food and Drug Administration (FDA) has approved Hadlima (adalimumab-bwwd; Samsung Bioepis), a biosimilar to Humira (adalimumab; Abbvie). The Food and Drug Administration (FDA) has approved Hadlima ...
Seeking Alpha

Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a ...

--Samsung Bioepis Co., Ltd. and Organon& Co. today announced that the U.S. Food and Drug Administration has accepted for review the Supplemental Biologics License Application for the ...
Seeking Alpha

US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA™ (adalimumab-bwwd) Injection

“This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no ...
Monthly Prescribing Reference

FDA Approves Citrate-Free, High Concentration of Biosimilar Hadlima

Credit: FDA. The approval was based on data from a phase 1 study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of Hadlima 100mg/mL to 50mg/mL. The Food and Drug ...
Business Wire

REPEAT/Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

JERSEY CITY, N.J. & INCHEON, Korea--(BUSINESS WIRE)--Organon & Co. (NYSE: OGN) & Samsung Bioepis Co., Ltd. announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is ...
Medscape

FDA Approves Adalimumab-bwwd Biosimilar (Hadlima) in High-Concentration Form

The US Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner ...
Business Insider

HADLIMA® (adalimumab injection) Now Available for the Treatment of Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing ...

HADLIMA ® is a biosimilar biologic drug (biosimilar) to the reference biologic drug HUMIRA ®. A biosimilar is authorized based on its similarity to a reference biologic drug that was already ...
Nasdaq

Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a ...

INCHEON, South Korea and JERSEY CITY, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the U.S. Food and Drug Administration (FDA) ...
Nasdaq

Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

Autoinjector recognized by the Arthritis Foundation with Ease of Use Certification Individualized patient support program “HADLIMA For You” available including co-pay support Designed to improve ...
Business Insider

Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a ...

Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing ...