Adalimumab biosimilar is under clinical development by Celltrion and currently in Pre-Registration for Plaque Psoriasis (Psoriasis Vulgaris). According to GlobalData, Pre-Registration drugs for Plaque Psoriasis (Psoriasis Vulgaris) have a 93% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Adalimumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Adalimumab biosimilar overview
Adalimumab (Yuflyma) is a human monoclonal IgG1 antibody. It is formulated as solution for subcutaneous route of administration. Yuflyma in combination with Methotrexate is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondylo arthritis including ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, non-infectious uveitis in adult and paediatric, plaque psoriasis in adult and adolescent and hidradenitis suppurativa, and non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate.
CTP-17 (adalimumab biosimilar) is under development for the treatment of rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn’s disease (CD), pediatric Crohn’s disease , ulcerative colitis (UC), uveitis (UV) and pediatric uveitis.
Celltrion is a biopharmaceutical company that focuses on the research, development, and manufacture of biosimilars and novel biopharmaceuticals. The company offers monoclonal antibodies for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn’s disease, psoriatic arthritis, and psoriasis. Its pipeline portfolio spans monoclonal antibody biosimilars for the treatment of rheumatoid arthritis; colorectal cancer; and respiratory disease; and antibody biologics and vaccines for infectious diseases such as hepatitis B, influenza, rabies, breast cancer, and seasonal influenza. Celltrion develops drugs by using its bioengineering and mammalian cell-culture technology. The company also carries out contract manufacturing of biosimilars. It has an operational presence in Korea, Russia, the UK, and the US. Celltrion is headquartered in Incheon, South Korea.
For a complete picture of Adalimumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.