2024-04-23 18:55:39
Product approval 2 months after European ‘positive opinion’
Expected to dominate the market ahead of original substance patent expiration
Lineup of 4 autoimmune disease treatments completed
Samsung Bioepis’ Stelara biosimilar has obtained product approval in Europe as well as in Korea.
Samsung Bioepis announced on the 23rd that its Stelara biosimilar ‘Pizchiba (SB17, ingredient name: ustekinumab, domestic product name: Epiztec)’ has received product approval from the European Commission (EC).
Fiz Chiba is the fourth autoimmune disease treatment developed by Samsung Bioepis, following Benepali, Flixavi, and Imraldi. The final product approval was obtained about two months after obtaining a positive opinion on product approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in February. After receiving approval from the Ministry of Food and Drug Safety early this month, European product approval was secured in just 10 days.
Fiz Chiba’s original medicine, Stellara, was developed by Janssen. It is prescribed for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It has a mechanism to suppress the activity of interleukin (IL)-12·23, a type of inflammatory cytokine involved in immune responses. Annual global sales are approximately 14 trillion won. In particular, many domestic companies are developing biosimilars ahead of the expiration of the Stellar substance patent. Competition in development and launch is so intense that all major companies are approaching final product approval in Europe and the United States. Samsung Bioepis is said to be in an advantageous position to dominate the market by first obtaining product approval in Korea and Europe.
Samsung Bioepis currently has three autoimmune disease treatments (Enbrel, Remicade, and Humira biosimilars), two anticancer drugs (Herceptin, Avastin biosimilar), and one eye disease treatment (Lucentis biosimilar) in the European market. , commercialized a total of 7 types of biosimilar products, including 1 blood disease treatment drug (Soliris biosimilar). With the approval of Fiz Chiba in Europe, it will be possible to expand its autoimmune disease treatment portfolio to include interleukin inhibitors along with the three existing tumor necrosis factor alpha (TNF-α) inhibitors (Benepali, Flixavi, and Imraldi).
Byeong-in Jeong, managing director of Samsung Bioepis’ RA (Regulatory Affairs) team, said, “We will continue to strive to provide more treatment options to patients through securing treatments for various autoimmune diseases and developing medicines.”
Sales of Fizz Chiba in the European market are handled by Sandoz, a Swiss biopharmaceutical company affiliated with Novartis. Samsung Bioepis and Sandoz signed a partnership agreement to sell Fiz Chiba in Europe and North America in September last year.
Kim Min-beom, Donga.com reporter [email protected]
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2024-04-23 18:55:39