Samsung Bioepis gets FDA nod for biosimilar Hadlima

Samsung Bioepis has received the Food and Drug Administration’s blessing for Hadlima (adalimumab-bwwd), a biosimilar of AbbVie's Humira (adalimumab).

The product is used 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. It also is Samsung Bioepis’ fourth biosimilar approved, following the approval of Renflexis (infliximab-abda) in April 2017, Ontruzant (trastuzumab-dttb) in January 2019, and Eticovo (etanercept-ykro) in April 2019.

"With the approval of Hadlima, we are proud to have three anti-TNF biosimilars approved in the United States. We believe the U.S. healthcare system can benefit from biosimilars which could play a critical role in broadening access to treatment options for patients with autoimmune conditions across the country," Samsung Bioepis senior vice president and head of regulatory affairs Hee Kyung Kim said. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems can benefit from biosimilars.”

Hadlima will be commercialized by Merck. It is expected to launch after June 30, 2023, in accordance with a licensing agreement signed with AbbVie.