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Celltrion's Ustekinumab Biosimilar (CTP-43) Enters Pre-Registration for Psoriatic Arthritis

• Celltrion's ustekinumab biosimilar, CTP-43, is in pre-registration for psoriatic arthritis, indicating a high likelihood of progressing to market availability. • CTP-43, a human monoclonal antibody, targets interleukin 12 subunit beta and interleukin 23 subunit alpha, offering a subcutaneous treatment option. • Celltrion leverages its bioengineering and cell-culture technology to develop biosimilars and novel biopharmaceuticals for various diseases. • GlobalData's analysis suggests a 100% phase transition success rate for psoriatic arthritis drugs in pre-registration, highlighting CTP-43's potential.

Celltrion's ustekinumab biosimilar, CTP-43, is currently in pre-registration for the treatment of psoriatic arthritis. This development signals a significant step towards market availability, supported by GlobalData's analysis indicating a 100% phase transition success rate (PTSR) for drugs in pre-registration for this indication.

Mechanism of Action and Clinical Development

CTP-43 is a human monoclonal antibody administered subcutaneously. It functions as an immunosuppressant by targeting the interleukin 12 subunit beta and interleukin 23 subunit alpha. This mechanism is crucial in managing the inflammatory response associated with psoriatic arthritis, plaque psoriasis, ulcerative colitis, and Crohn's disease, all of which are potential indications for CTP-43.

Celltrion's Expertise in Biosimilars

Celltrion, a biopharmaceutical company based in Incheon, South Korea, specializes in the research, development, and manufacturing of biosimilars and novel biopharmaceuticals. Their portfolio includes monoclonal antibodies for treating rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, psoriatic arthritis, and psoriasis. The company employs bioengineering and mammalian cell-culture technology to develop its drugs.

Market Potential and GlobalData Analysis

GlobalData's assessment of CTP-43 includes drug-specific PTSR and Likelihood of Approval (LoA) scores compared to indication benchmarks. The pre-registration status for psoriatic arthritis suggests a promising outlook for CTP-43, given the historical success rate of drugs at this stage. Ustekinumab (Steqeyma) is already approved for the treatment of Crohn's disease, plaque psoriasis, psoriatic arthritis and ulcerative colitis.
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Reference News

[1]
Ustekinumab biosimilar by Celltrion for Psoriatic Arthritis: Likelihood ...
pharmaceutical-technology.com · Dec 20, 2023

Ustekinumab biosimilar, developed by Celltrion, is in Pre-Registration for Psoriatic Arthritis, with a 100% phase transi...

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