Samsung Bioepis' Hadlima biosimilar approved in Canada

3 January 2023

South Korea’s Samsung Bioepis says that Health Canada has approved its Hadlima (also known as SB5) - a citrate-free, high concentration (40mg/0.4 ML) formulation of biosimilar referencing AbbVie’s (NYSE: ABBV) mega-blockbuster Humira (adalimumab).

Hadlima is indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, adult Crohn’s disease, ulcerative colitis, adult and adolescent hidradenitis suppurativa, plaque psoriasis, adult and pediatric uveitis.

The biosimilar is already approved in several countries, including the USA, where it is prevented from being launched until June 30 this year as per the terms of a licensing agreement signed with AbbVie.

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