3 Korean companies accelerate Stelara biosimilar development

"will complete clinical trials within the year”

Samsung Bioepis completes patient enrollment for its Phase III SB17 trial… plans to complete study in December

Stelara patent expiry imminent… expires in 2023 in the US and 2024 in Europe

Celltrion·Dong-A ST to also complete clinical trials within the year

Korean companies are rushing to get a share of Stelara’s autoimmune disease treatment market that brings in ₩9 trillion in annual sales.

 

Samsung Bioepis, which had been late in starting the development of Stelara biosimilars than its competitors like Dong-A ST and Celltrion, completed patient recruitment for its Phase III trial and pulled forward its study completion date.

 

All three companies are expected to complete clinical trials for the commercialization of their Stelara biosimilars within this year.

 

According to ClinicalTrals.gov, the clinical information website operated by the US National Institutes of Health, on the 19th, Samsung Bioepis had recently completed patient enrollment for its global Phase III clinical trial for SB17 (Name of Stelara biosimilar in development).

 

The company completed patient recruitment in only 6 months since the company started Phase III trials in July last year.

 

This Phase III trial that is being conducted in patients with moderate-to-severe plaque psoriasis registered 503 patients, exceeding the company's initial goal of enrolling 464 patients.

 

The expected completion date was also pulled forward from March 2023 to December this year.

 

Such moves are interpreted as Samsung Bioepis’s effort to accelerate the development of SB17.

 

Stelara is an IL-12 and 23 inhibitor developed by the multinational pharmaceutical company Janssen.

 

It is used to treat autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

 

In 2020, the drug raised $7,707,000,000 (approximately ₩9,155,900,000,000 based on exchange rates on the 18th) in global sales.

 

However, Stelara will soon face competition with latecomers as its substance patent expires in the US in September 2023 and Europe in July 2024.

 

In other words, the mega-market that brings in ₩9 trillion a year will soon be open for entry by biosimilars from September next year.

 

With Samsung Bioepis pulling forward its clinical trial completion date, Celltrion and Dong-A ST are also planning to complete their clinical trials for their Stelara biosimilar within this year.

 

Celltrion will be completing its trial in the first half of this year, and Dong-A ST in the second half of this year.

 

Celltrion’s Stelara biosimilar, CT-P43, is being developed the fastest.

 

Celltrion started Phase III trials for CT-P43 in January last year and completed patient enrollment with 509 patients in May of the same year.

 

The company is in its final stages of the trial and is expecting trial completion by May this year.

 

Celltrion plans to commercialize CT-P43 in line with Stellara's substance patent expiry in the US and Europe.

 

If the company keeps up its pace of development, the company is expected to be able to easily enter the global core market.

 

Dong-A ST is also speeding up its clinical trial for DMB-3115, its Stelara biosimilar in development.

 

Dong-A ST started global Phase III trials for DMB-3115 in April last year.

 

In November of the same year, the company completed enrolling 605 patients for the trial.

 

Dong-A ST plans to complete the Phase III trial for DMB-3115 in November this year.

 

Dong-A Socio Holdings and Meiji Seika Pharma had been jointly developing DMB-3115 since 2013.

 

In July 2020, the right to develop and commercialize DMB-3115 was transferred from Dong-A Socio Holdings to Dong-A ST.

 

Currently, the drug is being jointly developed by Dong-A ST and Meiji Seika Pharma.

 

The two companies have also completed preparations for the global commercialization of the drug.

 

In July last year, Dong-A ST and Meiji Seika Pharma signed a global license-out agreement for DMB-3115 with Intas Pharmaceuticals, transferring the rights for approval and marketing of DMB-3115 in the global region, excluding Korea, Japan, and some Asian countries.

 

An industry official said, “Biosimilars earn a profit by taking a piece of the original’s market share of the pie.

 

Therefore, earlier entry is beneficial to accumulate prescription data, etc.”