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

Hadlima Designated Interchangeable Biosimilar to Humira

The approval of the interchangeable designation was supported by data from a randomized, double-blind phase 4 trial (ClinicalTrials.gov Identifier: NCT05510063) that assessed the pharmacokinetics, ...
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 ...
WTEN

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) ...