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…
As we previously reported, earlier this year Merck announced that it would be spinning off its women’s health, biosimilars, and established brands businesses into a standalone company. This month, Merck completed the spinoff, creating Organon. Organon’s portfolio contains about 60 treatments and products, and mainly focuses on ex-US markets. Organon…
On March 17, 2021, Merck announced that it had filed a Form 10 registration statement with the U.S. Securities and Exchange Commission in order to spinoff its women’s health, biosimilars and established brands businesses into a standalone, publicly traded company, named Organon. Merck explained that Organon’s vision is to “create…