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– Global Market Expansion Accelerating With Back-to-Back FDA and EC Approvals
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SEOUL, South Korea – Dong-A ST (CEO: Jeong Jae-hoon, KRX: 170900) proudly announces that the Stelara biosimilar, IMULDOSA (Project Name: DMB-3115, Active Ingredient: Ustekinumab), received marketing authorization from the European Commission (EC) as of 18 December.
This landmark approval comes just two months after the Committee for Medicinal Products for Human Use (CHMP) under the European Medicine Agency (EMA) recommended that the product be approved in October. Combined with its successful US Food and Drug Administration (FDA) approval in October, IMULDOSA it is now fully authorized to enter the world market.
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IMULDOSAthe reference biosimilar Stelara by Janssen Pharmaceuticals, is indicated for the treatment of inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
Stelara, with its active ingredient ustekinumab, is among the top biologics worldwide, generating $20.323 billion in global sales by 2023, according to IQVIA.
Development of IMULDOSA started in 2013 as a joint project between Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, the development and sales rights held by Dong-A Socio Holdings were transferred to Dong-A ST to ensure the successful implementation of the global project. Since then, Dong-A ST and Meiji Seika Pharma have continuously worked together to develop it.
In July 2021, Dong-A ST signed a global license agreement with international pharmaceutical company Intas Pharmaceuticals IMULDOSA. Through Intas and its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the UK and Canada, IMULDOSA is set to be launched in more regions.
A Dong-A ST representative commented, “With successive approvals in the United States and Europe, IMULDOSA now it is one step to enter the global pharmaceutical market. We will continue to dedicate our efforts to ensure that IMULDOSA is establishing a strong presence in the market, providing an effective treatment option to patients worldwide. “
View the source version on businesswire.com: https://www.businesswire.com/news/home/20241219254328/en/
Contacts
Dong-A ST CO., Ltd
Shin-Hee Park
+82-32-610-2481
sh-park@donga.co.kr
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