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 ...
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

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 ...
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 ...
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 ...
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) ...