Celltrion's 'Stelara' Biosimilar Phase 3 Clinical Trial Success... Targeting 13 Trillion Won Market

Efficacy and Safety Confirmed in Phase 3 Clinical Trial
Oral Presentation Scheduled at EADV on the 9th

Amgen, Alvotech, and Epis Also Developing
Amgen Aims for 'Interchangeability'

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Lee Chun-hee] Celltrion has succeeded in the Phase 3 clinical trial of the biosimilar for the autoimmune disease treatment drug 'Stelara' (generic name ustekinumab). With the patent expiration scheduled for next year, it plans to take the lead in the market by completing the clinical trial first among domestic developers.

Celltrion announced on the 7th that it will present the 28-week results of the global Phase 3 clinical trial of 'CT-P43', a Stelara biosimilar under development, at the European Academy of Dermatology and Venereology (EADV Congress) on the afternoon of the 9th (local time).

Marking its 31st year this year, the EADV is a prestigious European dermatology conference. It will be held simultaneously on-site in Milan, Italy, and online over four days from the 7th to the 10th. Celltrion plans to give an oral presentation of the 28-week results of the CT-P43 global Phase 3 clinical trial involving 509 patients with plaque psoriasis during the 'Late Breaking News' session at this conference.

CT-P43 entered the global Phase 3 clinical trial in December 2020, completed patient recruitment in May last year, and proceeded with the trial. The trial was conducted by dividing patients into Stelara and CT-P43 groups, and from week 16, the Stelara group was switched to CT-P43, with results analyzed up to week 28.

The 28-week clinical results demonstrated efficacy equivalence between the Stelara and CT-P43 groups, and safety similarity was also confirmed. Monitoring for 12 weeks after switching from Stelara to CT-P43 showed that efficacy was similarly maintained compared to Stelara, with no significant adverse reactions after drug administration.

Janssen (a subsidiary of Johnson & Johnson)'s autoimmune disease treatment 'Stelara (active ingredient Ustekinumab)'

Stelara, developed by Janssen, a subsidiary of Johnson & Johnson, is a blockbuster drug for treating autoimmune diseases such as psoriasis, arthritis, Crohn's disease, and ulcerative colitis, generating sales of $9.134 billion (approximately KRW 12.6679 trillion) last year alone. As the substance patent expires in the US in September next year and in Europe in July 2024, fierce competition is underway in the biosimilar development market. Besides Celltrion, Samsung Bioepis, Dong-A ST, Amgen, and Alvotech are also developing biosimilars.

Among overseas big pharma companies, Amgen was the first to succeed in Phase 3 clinical trials. In April, Amgen announced that the Phase 3 trial of 'ABP-654' met the primary efficacy endpoints and showed no clinically meaningful differences from the original drug. Amgen began additional trials last year to obtain approval for 'interchangeable biosimilar' status, going beyond a simple biosimilar.

Becoming an interchangeable biosimilar allows pharmacists to substitute the original drug independently, giving a competitive advantage over other biosimilars. Moreover, even if the original developer tries to maintain market share by expanding indications, extrapolation to other indications of the original drug is possible, enabling easier response.

Alvotech also announced in May that its biosimilar 'AVT-04' met the primary endpoints in the Phase 3 clinical trial and confirmed equivalence to Stelara.

Domestically, Samsung Bioepis and Dong-A ST are also pursuing biosimilar development. Samsung Bioepis began a Phase 3 clinical trial of 'SB17' for psoriasis patients last July, targeting 464 patients across eight countries. 'DMB-3115', jointly developed by Dong-A ST and DM Bio under the Dong-A Socio Group, completed the registration of 605 patients for the global Phase 3 trial last November and plans to complete the trial within this year.

This content was produced with the assistance of AI translation services.