Dong-A ST’s biosimilar first enters the U.S. market

…makes R&D advancements

Dong-A ST’s Stelara biosimilar Imuldosa receives FDA approval

Declared entry into the biosimilar market in 2011...Built a bio factory in Songdo

Had released a Nesp biosimilar in Japan in 2019…equipped with a new product

Dong-A S.T.

 

has succeeded in entering the US market 13 years after declaring its entry into the biosimilar business.

 

It has received approval in the US for a biosimilar version of Stelara, which owns a global market worth KRW 14 trillion.

 

It was the company’s second overseas market with a self-developed biosimilar.

 

The biosimilar's entry into the U.S.

 

market secured additional technology fee revenues and added a new item for the company.

 

Pic of Dong-A ST headquarters

According to industry sources, Dong-A ST's Stelara biosimilar ‘Imuldosa’ was approved by the US Food and Drug Administration (FDA) on the 12th.

 

Stelara is a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

 

It is a high-grossing product that generated more than KRW 14 trillion in global sales last year.

 

Dong-A ST is the second Korean company to receive approval for a Stelara biosimilar in the US following Samsung Bioepis.

 

Dong-A ST passed the US market gateway 11 years after it started developing its Stelara biosimilar in 2013.

 

Dong-A Socio Holdings began codeveloping Imuldosa with Japan's Meiji Seika Pharma in 2013.

 

In July 2020, the development and commercialization rights were transferred to Dong-A ST for efficient execution of the global project.

 

From 2021 to the end of 2022, Dong-A ST conducted a global Phase III clinical trial of Imuldosa in 9 countries including the United States, Poland, and Estonia, on a total of 605 patients.

 

Trial results confirmed that Imuldosa’s efficacy and safety was equivalent to is equivalent to Stelara for marketing authorization by the U.S.

 

Food and Drug Administration (FDA) and European Medicines Agency (EMA) Imuldosa's FDA approval is expected to generate additional technology fees.

 

In July 2021, Dong-A ST signed a technology export agreement with the multinational pharmaceutical company Intas Pharmaceutical to license out Imuldosa.

 

Intas paid a non-refundable upfront payment of USD 10 million.

 

The payments based on clinical, licensing, and sales milestones were set at up to USD 95 million.

 

Royalties on product sales are guaranteed to be at least 10%.

 

In addition, payments from Intas will be shared by Dong-A ST, Dong-A Socio Holdings, and Meiji Seika Pharma.

 

Intas has secured exclusive rights to license and market the product globally, excluding South Korea, Japan, and select Asian countries.

 

Intas is an Indian multinational pharmaceutical company with a global sales network in more than 85 countries.

 

Global commercialization will be handled by Accord Healthcare, a subsidiary of Intas Pharmaceuticals.

 

Accord Healthcare submitted a marketing authorization application for Imuldosa to the European Medicines Agency (EMA) in June last year and submitted an application to the FDA in October last year.

 

By the end of the first half of last year, Dong-A ST had recognized KRW 41 billion as development costs for Imuldosa as an intangible asset.

 

The Financial Supervisory Service has identified Phase III clinical trials as the stage at which new drug R&D costs can be capitalized.

 

This means that KRW 41 billion was spent on global Phase III clinical trials of Imuldosa.

 

Dong-A ST announced its entry into the biosimilar business in 2011.

 

In 2011, Dong-A Socio Holdings established DM Bio with an investment of KRW 57 billion from Meiji Seika Pharma to build a biopharmaceutical plant.

 

In March 2015, Dong-A Socio Holdings spun off DM Bio into a 100% subsidiary and transferred 49% of its shares to Meiji Seika Pharma.

 

In 2021, Dong-A Socio Holdings acquired 1,117,200 shares of DM Bio from Meiji Seika Pharma for KRW 42.1 billion.

 

The company's stake in DM Bio increased to 80.4% as it took over 60% of the 1.86 million DM Bio’s shares held by Meiji Seika Pharma.

 

In 2022, DM Bio changed its name to STgen Bio.

 

STgen Bio will be responsible for the production of Imuldosa.

 

Imuldosa is the second biosimilar product that Dong-A ST has successfully commercialized in overseas markets.

 

Dong-A ST sells Nesp's biosimilar version, ‘darbepoetin alfa’ in Japan.

 

Dong-A ST conducted Phase I clinical trials of darbepoetin alfa and transferred the development and sales rights in Japan to Sanwa Kagaku Kenkyusho (SKK) in January 2014.

 

Based on the results of a local Phase III clinical trial comparing the original Nesp with darbepoetin alfa, SKK received marketing authorization from the Japanese Ministry of Health, Labour and Welfare in September 2019, and launched the drug in late November of the same year.

 

Dong-A ST will export the finished product manufactured on consignment by STgen Bio to SKK, and SKK is in charge of local sales.

 

Last year, Dong-A ST recorded 20.6 billion won in exports with its dabepoetin alfa.