Samsung Bioepis said Thursday that the U.S. Food and Drug Administration has accepted the company’s biologics license application (BLA) for SB5, a biosimilar candidate referencing Humira (Ingredient: adalimumab).
Humira is one of the world’s most purchased biomedicine with an estimated 18 trillion won ($15 billion) in sales. It has applications for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, and uveitis.
The BLA review comes after the company conducted a randomized, double-blinded 52-week phase-3 clinical trial study. The study involved 544 patients with moderate to severe rheumatoid arthritis after undergoing methotrexate therapy.
The company either administered SB5 or the adalimumab reference product (ADL) to the participants. At week 24, the rate of American College of Rheumatology 20 Response (ACR20) for SB5 group was 72.4 percent compared to the 72.2 percent in the ADL group. The safety profile of SB5 was also comparable to the ADL group up to week 24.
After week 24, the company randomly divided the 254 patients receiving ADL to continue treatment with ADL or transit to SB5, while the remaining 254 patients continued to receive SB5.
Up to week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment-emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.
If approved, the company will be able to market its drug in the U.S. after 2023, following a licensing agreement with AbbVie, the original drug developer, in April.
Samsung Bioepis and AbbVie agreed that the Korean company would be eligible to launch Imraldi (SB5’s EU brand name) in Europe from Oct. 16 and in the U.S. after June 30, 2023.
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