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Samsung Bioepis

Samsung Bioepis

(Seoul = Larose.VIP) Reporter Kim Hyun-soo = Samsung Bioepis has confirmed the possibility that ‘SB17’, a biosimilar (biopharmaceutical copy) for the treatment of autoimmune diseases, can be used for all diseases for which the original drug Stelara is effective. 22 The day was revealed.

Samsung Bioepis announced that it presented two abstracts on the clinical follow-up research results of ‘SB17’ at the European Society of Crohn’s Disease and Colitis annual conference held in Stockholm, Sweden from the 21st to the 24th (local time).

According to Samsung Bioepis, as a result of confirming the comprehensive evidence based on the physicochemical, non-clinical, and clinical equivalence of SB17 and Stelara, it was found that not only the plaque psoriasis for which clinical trials were conducted, but also the remaining indications possessed by the original drug (whether the drug has a therapeutic effect) The possibility of treating visible diseases has been confirmed.

Generally, biosimilars are clinically conducted for one indication, but the remaining indications of the original drug can also be recognized through comprehensive evidence combining analytical, non-clinical, and clinical results.

Along with these results, the company added that the structural, physicochemical, biophysical, and biological equivalence of SB17 and Stelara was also confirmed.

Samsung Bioepis completed the phase 3 clinical trial of SB17 on 503 patients with moderate and severe plaque psoriasis in eight countries around the world in November 2022 and confirmed its equivalence to the original drug.

Kim Hye-jin, head of the Samsung Bioepis Medical Team, said, “Through the abstract released through this academic conference, we once again demonstrated the equivalence between our product and the original drug,” and added, “Based on the research results, biosimilar treatment opportunities are available to more patients.” “We will do our best to provide this,” he said.

hyunsu@yna.co.kr

Report to KakaoTalk okjebo 2024/02/22 09:47 Sent

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