[서울=뉴스핌] Reporter Kim Yang-seop = Samsung Bioepis (CEO Han-seung Ko) received approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) to sell Prolia and Received a positive opinion on product approval for Xgeva’s biosimilars Obodence & Xbryk (project name SB16, ingredient name denosumab). It was announced on the 17th that it had been acquired.
Samsung Bioepis has received approval recommendations in Europe for two products, Prolia biosimilar ‘Obodence’ and Xzyva biosimilar ‘Xbrick’, for each indication, just like the original drug, and they are usually approved for about 2 to 3 months. It is expected that official sales approval will be obtained after the necessary final review by the European Commission (EC).
Samsung Bioepis has currently launched a total of eight biosimilar products3) in the European market, including Opuviz™ (Eylea biosimilar, ingredient name aflibercept), an eye disease treatment that received approval recommendations in September. ), if Obodence and Xbrick also receive official approval, a total of 11 biosimilar products will be secured in Europe.
Samsung Bioepis RA (Regulatory Affairs) Team Leader Byeong-in Jeong said, “Through this European approval recommendation, we have once again proven our global level R&D capabilities, and have the opportunity to treat more patients using biosimilars through our diverse product portfolio. “We will continue to work hard to provide this.”
Meanwhile, Samsung Bioepis conducted a study on the efficacy and safety between SB16 (the project name of Obodense and A global clinical trial was conducted to compare .
Subsequently, the clinical equivalence between SB16 and the original drug was proven by disclosing phase 1 and 3 clinical data at the American Society for Bone and Mineral Research (ASBMR) annual conference in October last year.
