Three Korean pharmaceutical companies are in a fierce race to develop a biosimilar of Stelara (ustekinumab), a treatment for autoimmune diseases.
Samsung Bioepis, Celltrion, and Dong-A ST have received authorization to conduct global phase 3 trials of Stelara biosimilars.
Recently, Dong-A ST finished patient recruitment, following Celltrion.
The three companies hope to release Stelara biosimilars in time for the expiration of Stelara’s patent.
Dong-A ST said on Friday that it completed patient enrollment for global phase 3 trials of DMB-3115, an investigational biosimilar of Stelara. The company recruited 605 patients with moderate to severe chronic plaque psoriasis for trials in the U.S. and nine countries in Europe, including Poland, Estonia, and Latvia.
Dong-A Socio Group and its affiliate Dong-A ST have been working on DMB-3115 as a major R&D project for a long time.
Dong-A Socio Holdings, which owns a 23.32 percent stake in Dong-A ST, and Japan’s Meiji Seika Pharma have jointly developed the biosimilar since 2013.
In July 2020, Meiji Seika Pharma handed over the right to develop and commercialize DMB-3115 to Dong-A Socio Holdings.
In July 2021, Dong-A ST and Meiji Seika Pharma licensed out DMB-3115 to Intas Pharmaceuticals.
Under the agreement, Intas got the exclusive rights concerning approval and marketing of DMB-3115 in the global market, except for Korea, Japan, and some Asian countries.
Dong-A ST and Meiji Seika Pharma will research and develop the biosimilar and have the right to the exclusive supply of finished products.
Dong-A ST and Meiji Seika Pharma will get an upfront payment of $10 million, milestone payments of $95 million, and double-digit royalties on the product's sales revenue from Intas Pharmaceuticals.
Dong-A ST finished a phase 1 study in Europe in May and plans to end global phase 3 trials in the second half of 2022.
Announcing quarterly earnings this year, the company repeatedly said it would focus on the global development of DMB-3115 in 2021.
Celltrion also plans to end clinical trials of CT-P45, a biosimilar of Stelara, in the second half of 2022.
The company said it completed enrolling patients for global phase 3 trials in May, six months after patient recruitment in December 2020. The study tests the biosimilar on 509 patients in Estonia.
Celltrion also completed a phase 1 study on 271 participants in New Zealand in August to prove the bioequivalence of the biosimilar.
Celltrion plans to commercialize CT-P43 in time for Stellara's substance patent expiration in the U.S. in September 2023 and Europe in July 2024.
Samsung Bioepis, working on the Stelara biosimilar SB17, is still enrolling patients.
The company began global phase 3 trials in patients with moderate to severe plaque psoriasis in July. It plans to recruit 464 patients in eight countries, including Korea, Poland, and the Czech Republic.
Samsung Bioepis is also recruiting 201 healthy adults for a phase 1 study in France in February.
Samsung Bioepis plans to finish global phase 3 trials by March 2023, slightly behind the schedule of the other two, Celltrion and Dong-A ST.
Stelara is an interleukin (IL)-12, 23 inhibitor developed by Janssen. It is used to treat inflammatory autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
According to Johnson & Johnson, the parent firm of Janssen, Stelara sold about $7.7 billion a year globally.