Samsung Bioepis Announces Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar in Canada

On January 3, 2023, Samsung Bioepis announced that Health Canada has approved their citrate-free, high concentration (40 mg/0.4 mL) HUMIRA biosimilar, HADLIMA (also known as SB5). 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 low-concentration HADLIMA was previously approved by Health Canada as a low-concentration (40 mg/0.8 mL) formulation in May 2018. In Canada, the low-concentration formulation was launched in February 2021 in partnership with Organon. The citrate-free, high-concentration HADLIMA will also be commercialized by Organon, later in 2023. As we previously reported, the FDA approved of high-concentration HADLIMA in August 2022.