Korean drugmakers race to release Stelara biosimilars

South Korea’s major drugmakers such as Celltrion Inc., Samsung Bioepis and Dong-A St are going for broke to release biosimilars of Stelara, Johnson & Johnson’s blockbuster drug for autoimmune disorders. Stelara, a prescription medicine developed by Johnson & Johnson’s pharmaceutical unit Janssen, generated $7.7 billion in revenue last year. Those South Korean biopharmaceutical companies are jostling to capture the market as Stelara’s US patent is scheduled to expire in two years.

DONG-A ST INKS LICENSE-OUT DEAL WITH INDIA’S INTAS

Dong-A ST and its Japanese partner Meiji Seika Pharma Co. signed a $105 million license-out agreement with India’s Intas Pharmaceuticals for DMB-3115, a Stelara biosimilar, the South Korean company said on July 21. Aside from a $10 million down payment with no obligation to return, the licensors will receive technology fees of $95 million for each clinical stage and 10% or more of sales as royalties. Dong-A ST has rights to sell in South Korea, Japan, and some Asian countries, while Intas has sales rights in major global markets such as the US and Europe. Intas plans to sell the product through its wholly owned subsidiary Accord Healthcare in the UK. The Indian company has the advantage in capturing developed markets as it generates 70% of its revenue in the US and Europe, according to Dong-A ST.

Its holding company Dong-A Socio Holdings, which started developing DBM-3115 with Meiji Seika Pharma, transferred rights of the biosimilar’s development and commercialization to Dong-A ST July last year. DM Bio, Dong-A Socio Holdings’ contract development and manufacturing organization (CDMO), will produce it.

Dong-A ST launched Phase 3 trials in Poland, Estonia, Latvia, and the US during the first quarter of this year and plans to conduct more trials in nine European countries sequentially.

Stelara is a medicine that treats inflammatory diseases such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Janssen’s Remicade, AbbVie Inc.’s Humira and Amgen’s Enbrel are used for treatments of similar diseases. All of these products' patents have expired, and biosimilar products such as Celltrion's Remsima are on the market.

Stelara’s patents expire in September 2023 in the US and July 2024 in Europe. It is effective for patients who have developed resistance or do not respond to "tumor necrosis factor (TNF)-α" drugs such as Remicade, Humira, and Enbrel.

CUTTHROAT COMPETITION

Global competition for Stelara’s biosimilars is already fierce. In South Korea, Celltrion led the development. It started Phase 3 clinical trials in Europe in January with an aim to complete clinical trials in the second half of next year. It has already recruited 509 patients for the trials. Celltrion has a diverse autoimmune disease portfolio such as the successful development of biosimilars of Remicade and Humira. Samsung Bioepis, which developed Humira’s biosimilar, also entered Phase 3 trials in eight countries, including Poland and the Czech Republic, earlier this month.

Global players are actively developing Stelara’s biosimilars. Amgen is currently carrying out Phase 3 trials and aims to complete these in August of next year. China’s Bio-Thera Solutions launched Phase 3 trials and targets completing these by May 2023.

Write to Ju-Hyun Lee and Woo-Sub Kim at deep@hankyung.com
Jongwoo Cheon edited this article.