Samsung Bioepis' Humira biosimilar approved both in high and low concentration in US

[Source: Samsung Bioepis Co.]

The U.S. Food and Drug Administration (FDA) has approved a high-concentration (100 mg/mL) formulation of Hadlima, a biosimilar from Samsung Bioepis Co., which references Humira (adalimumab) from AbbVie, the Korean biopharmaceutical company said on Thursday.

Hadrima is indicated for the treatment of autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis, among others.

Hadlima was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019. The latest approval enables availability in both low and high concentration adalimumab biosimilar.

Under a patent agreement with AbbVie, Hadlima is expected to be launched on or after July 2023 by Organon & Co. in the U.S.

Hadlima is marketed by Biogen under the trade name of Imraldi in Europe and by Yuhan under the trade name of Adalloce in Korea. It was launched in October 2018 in Europe and May 2021 in Korea, with over 5 million doses sold since 2018.

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