secukinumab biosimilar (CT-P55) / Celltrion - LARVOL DELTA

Celltrion launches phase 3 trial for psoriasis biosimilar CT-P55 in Europe (Chosun Biz) - "Celltrion announced on the 18th that it has received approval from the European Medicines Agency (EMA) for the clinical phase 3 trial plan (IND) for the psoriasis treatment Cosentyx (COSENTYX, active ingredient secukinumab) biosimilar...and the substance patent will expire in the U.S. in January 2029 and in Europe in July 2030. With this approval, Celltrion will begin a global phase 3 clinical trial for CT-P55, a biosimilar of Cosentyx, involving 375 patients with plaque psoriasis."

New P3 trial • Patent • Immunology • Psoriasis

Celltrion Expands Autoimmune Disease Portfolio…'CT-P55' in Phase 3 in Europe [Google translation] (Health in News) - "Celltrion announced on the 14th that it has submitted an investigational new drug (IND) for the global phase 3 clinical trial of Cosentyx (ingredient: secukinumab) biosimilar 'CT-P55' to the Clinical Trials Information System (CTIS) managed by the European Medicines Agency. This phase 3 clinical trial will be conducted on 375 patients with plaque psoriasis, and will compare the efficacy and safety of the original drug Cosentyx and 'CT-P55' to demonstrate equivalence. Cosentyx is an interleukin (IL)-17A inhibitor widely used to treat autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis."

New P3 trial • Immunology • Psoriasis

A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Psoriasis (clinicaltrials.gov) - P3 | N=375 | Not yet recruiting | Sponsor: Celltrion

New P3 trial • Dermatology • Immunology • Psoriasis

Celltrion, Cosentyx Similar 'CT-P55' US Phase 3 IND Application [Google translation] (Hankyung) - "Celltrion announced that it has submitted an investigational new drug (IND) application for the global phase 3 clinical trial of Cosentyx (ingredient name: secukinumab) biosimilar 'CT-P55' to the U.S. Food and Drug Administration (FDA). This global clinical trial will involve a total of 375 patients with plaque psoriasis, and is a comparative study to prove the equivalence of efficacy and safety between the original drug and CT-P55."

IND • New P3 trial • Immunology • Psoriasis

Celltrion's Cosentyx biosimilar gets nod for phase 1 study in Japan (The Korea Herald) - "South Korean biosimilar giant Celltrion said Monday it has gained approval for a phase one clinical trial of CT-P55 from a Japanese regulatory authority....Upon approval from the Tokyo-based Pharmaceuticals and Medical Devices Agency, Celltrion will conduct a phase one clinical study with a total of 171 Japanese adults to compare the pharmaceutical equivalence of CT-P55 to Cosentix."

New P1 trial • Immunology • Psoriasis