FDA approves Hadlima an adalimumab biosimilar

Samsung Bioepis Co., Ltd. announced that the FDA has approved Hadlima (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab) , for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. Hadlima is Samsung Bioepis’ third anti-TNF biosimilar approved for marketing in the United States. Hadlima is also Samsung Bioepis’ fourth biosimilar approved in the U.S., following the approval of Renflexis (infliximab-abda) in April 2017, Ontruzant (trastuzumab-dttb) in January 2019, and Eticovo (etanercept-ykro) in April 2019.

In addition to the U.S., Samsung Bioepis’ adalimumab biosimilar has been approved for marketing in over 30 countries, including 28 European Union (EU) member states, Canada, Australia and Korea. Hadlima will be commercialized in the U.S. by Merck Inc., . Hadlima is expected to launch in the U.S. after June 30, 2023, in accordance with a licensing agreement signed with AbbVie Inc.