E Point Perfect
Law \ Legal

Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar


Last week Samsung Bioepis and Organon announced FDA approval of their citrate-free, high-concentration (100 mg/ml) HUMIRA biosimilar, HADLIMA (adalimumab-bwwd).  HADLIMA was previously approved by FDA as a low concentration (50 mg/ml) formulation in July 2019.  The low-concentration product has been available in various markets outside the United States, with over 5 million doses sold since 2018.  The press release states that HADLIMA is expected to launch in the United States on or after July 1, 2023.

The post Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar appeared first on Big Molecule Watch.



Source link

Related posts

TCDI is Acquiring Aon’s eDiscovery Practice: eDiscovery Trends

To ESG or Not: “Damned If You Do, Damned If You Don’t,” at Least in Some US States

Looking at Legislative Proposals that Would Allow Broadcasters to Accept Marijuana Advertising

US Executive Branch Update – August 22, 2022

FVAP seeking Exec Director – LexBlog

Department of Defense Debarment Enjoined Due to Procedural Missteps