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 ...
Business Wire

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 ...
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) ...