Dong-A ST, FDA approved phase 3 test
Celltrion plans to launch products in 2023
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Dong-A ST and Celltrion are fighting head-to-head in the biosimilar market of’Stellara’ (ingredient name: Ustekinumab) used for psoriasis treatment.
The global market of Stellara, an original drug, alone reaches 7 trillion won. Both companies have started developing biosimilars, and if Stellara’s patents begin to expire after 2023, the two companies are expected to compete in a fierce battle for the biosimilar market for this drug around the world.
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Dong-A ST announced on the 25th that it has been approved by the US Food and Drug Administration (FDA) for a phase 3 clinical trial of’DMB-3115′, a biosimilar (generic biopharmaceutical drug) used to treat psoriasis.
It is planning to conduct global clinical phase 3 using clinical samples produced by DM Bio, a subsidiary of Dong-A Socio Holdings. In phase 3, the efficacy, safety and immunogenicity of subcutaneous injections between biosimilar products and original drugs will be compared. Dong-A ST plans to initiate phase 3 clinical trials in the United States within the first quarter of this year and then apply for phase 3 clinical trials in nine European countries. It plans to launch biosimilars in the U.S. (September 2023) and Europe (July 2024) where the substance patent for Stellara expires after the clinical completion. Dong-A Socio Holdings has been promoting joint development with Meiji Seika Pharma since 2013. In July last year, the rights to development and commercialization were transferred to Dong-A ST to increase the efficiency of the business, and Dong-A ST and Meiji Seika Pharma are currently developing it jointly.
After the phase 3 clinical trial of Stellara is over, Dong-A ST and Celltrion, a domestic company, will face off in the biosimilar market. Earlier, in December of last year, Celltrion started a global phase 3 clinical trial for Stellara’s biosimilar’CT-P43′. Celltrion plans to release a product immediately after the substance patent expires by ending phase 3 clinical trials in the second half of next year.
Stellara is a biopharmaceutical developed by Janssen, a multinational pharmaceutical company, and is used to treat autoimmune diseases such as psoriasis, Crohn’s disease, and ulcerative colitis. Worldwide sales amounted to $6.36 billion (about 7 trillion won) as of 2019.
An official from Dong-A ST said, “It was slower to enter the clinical phase 3 than Celltrion, which started development, but because biosimilars can release products after the original product’s patent expires, the time to enter the clinical trial is meaningless if it can be successfully developed according to that time. “We will decide on the price and so on after looking at the situation.”
/ Reporter Joo-won Lee [email protected]
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