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Samsung Bioepis corporate image (CI)

Samsung Bioepis corporate image (CI)

(Seoul = Larose.VIP) Reporter Hong Guk-ki = SB17, a Samsung Bioepis biosimilar (biopharmaceutical generic drug) of the autoimmune disease treatment drug ‘Stellara’, is about to be officially sold in Europe under the name ‘Fizz Chiba’.

Samsung Epis announced on the 25th that it received a positive opinion on marketing approval for SB17 from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

The company explained that the name Fiz Chiba will only be used in Europe.

He added that Fiz Chiba is expected to obtain official sales approval after a final review by the European Commission (EC), which usually takes 2 to 3 months.

Fiz Chiba’s original medicine, Stellara, is a treatment for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis developed by Janssen.

It has a mechanism to suppress the activity of interleukin (IL), a neurotransmitter related to immune responses, and annual sales amount to approximately 14 trillion won.

Fiz Cheeba is the fourth autoimmune disease treatment developed by Samsung Bioepis.

Sandoz, a global biopharmaceutical company, will be responsible for selling Fiz Chiba in the European market.

Previously, Samsung Bioepis and Sandoz signed a partnership agreement to sell SB17 (Fiz Chiva) in North America and Europe. Samsung Bioepis completed the phase 3 clinical trial of SB17 at the end of 2022, and through the results of this study, clinical and medical equivalence between Stelara and SB17, including efficacy and safety, was confirmed.

Samsung Bioepis introduced that it has commercialized a total of 7 types of biosimilar products in the European market to date.

redflag@yna.co.kr

Report to KakaoTalk okjebo 2024/02/25 10:29 Sent

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