2024-04-12 08:27:03
Samsung Bioepis’ ‘Epidstech’ approved by the Ministry of Food and Drug Safety
Domestic approval for two formulations for intravenous injection and subcutaneous injection (SC)
Recommended for approval in Europe last February
Celltrion and Donga ST also begin global approval process
Samsung Bioepis, Celltrion, and Donga ST are expected to be launched in the U.S. next year in that order.
Samsung Bioepis announced on the 12th that it was the first in Korea to obtain product approval for the autoimmune disease treatment Stelara biosimilar ‘EPYZTEK (Developed name: SB17, Ingredient name: Ustekinumab)’ from the Ministry of Food and Drug Safety on the 11th.
The original drug, Stellara, is a global blockbuster product developed by Janssen. Annual global sales are approximately 14 trillion won. It has a mechanism to inhibit the activity of interleukin (IL)-12·23, a type of autoimmune-related inflammatory cytokine. It is used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
In the case of Samsung Bioepis, this time, it received product approval for two types of formulation: intravenous injection (Ⅳ) and subcutaneous injection (SC) formulation. The intravenous formulation is indicated for adults with Crohn’s disease and ulcerative colitis, and the SC formulation (Epistech Prefilled Injection) is indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis for adults, and for plaque psoriasis for pediatric patients. secured. With this product approval, Samsung Bioepis has added an interleukin inhibitor to its autoimmune disease treatment portfolio for the first time. It is the fourth autoimmune disease treatment to be successfully developed, following the three types of tumor necrosis factor alpha (TNF-α) inhibitors (Etoloche, Remaroche, and Adaloche).
In particular, competition to launch biosimilar products is intensifying ahead of the expiration of the original Stellar substance patent (expired in July of this year in Europe and September of last year in the United States). In addition to Samsung Bioepis, domestic companies such as Celltrion (CT-P43) and Donga ST (DMB-3115) are developing Stellara biosimilars. Since Samsung Bioepis is the most advanced in Korea, it is expected to have the advantage of taking the lead in the market.
Even overseas, Samsung Bioepis is making the fastest progress. All three companies have begun the product approval process, focusing on the U.S. and European markets. An agreement was reached with Janssen’s parent company, Johnson & Johnson, on other patents in addition to the material patent in the United States. According to the agreement, if product approval is obtained in the United States, Samsung Bioepis will be able to be launched in February of next year, Celltrion will be able to be sold locally in March, and Dong-A ST will be able to sell in May. Following Korea, Samsung Bioepis is able to pursue commercialization the fastest among domestic companies in the United States. Competition to develop Stellara biosimilars is expected to continue even after launch. Although it has not yet been released, Celltrion is known to be pursuing the development of an oral Stelara biosimilar with an American biotech company.
Analysis suggests that a European launch is even closer. Sales are expected to begin in earnest in the second half of this year. In particular, Samsung Bioepis received an approval recommendation (positive opinion for approval) for the Stelara biosimilar ‘Fiz Chiva (European product name)’ from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in February. In general, the pattern of formal item approval from EMA within 2 to 3 months following the CHMP approval recommendation continued. Celltrion and Donga ST are also expecting to launch their Stelara biosimilar in Europe within the year, but have not yet received approval recommendations from CHMP.
Byeong-in Jeong, managing director of the RA (Regulatory Affairs) team at Samsung Bioepis, said, “By obtaining product approval for a Stelara biosimilar for the first time in Korea, we are now able to provide new treatment options to patients.” He added, “Preparations for overseas launch are also on track. “We hope that more patients will be able to benefit from this new treatment option.”
Meanwhile, Samsung Bioepis conducted a phase 3 clinical trial of SB17 (Stellara biosimilar) on 503 patients with plaque psoriasis in a total of 8 countries, including Korea, from July 2021 to November 2022. Through this, clinical equivalence, including effectiveness and safety, compared to the original drug was confirmed.
Kim Min-beom, Donga.com reporter [email protected]
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2024-04-12 08:27:03