(Health Korea News / Si-Woo Lee) Samsung Bioepis (CEO Han-Seung Ko) announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has approved ‘Prolia’. About the product approval of ‘Obodence’ and ‘Xbryk’ (project name SB16, ingredient name denosumab), biosimilars of ‘Prolia’ and ‘Xgeva’ It was announced on the 17th that a positive opinion was presented. As a result, Samsung Bioepis is expected to soon be able to significantly expand its portfolio by obtaining European approval for a total of 11 biosimilars.
‘Prolia’ and ‘XGiva’ are biopharmaceuticals developed by Amgen. They differ in the dosage and administration cycle of the main ingredient, denosumab, to treat osteoporosis treatment ‘Prolia’ and ▲ bone metastasis. ‘XGiva’ was approved for the prevention of skeletal-related events (SRE) in patients and for the treatment of giant cell tumor of bone. Last year, the combined annual global sales of the two products were approximately 8 trillion won.
Samsung Bioepis received approval recommendations in Europe for two products, Prolia biosimilar ‘Obodence’ and Xzyva biosimilar ‘XBrick’, for each indication, the same as the original drug. With CHMP’s positive opinion, the two biosimilars are expected to receive official marketing approval after a final review by the European Commission (EC), which usually takes about 2 to 3 months. News of product approval is expected to be announced as early as the end of January next year.
Samsung Bioepis has currently launched a total of eight biosimilar products in the European market. 4 types of autoimmune disease treatments (Enbrel, Remicade, Humira, and Stelara biosimilars), 2 anticancer drugs (Herceptin and Avastin biosimilars), 1 type of eye disease treatment (Lucentis biosimilar), and blood and kidney disease treatments. Type 1 (Soliris biosimilar) is that.
Previously, CHMP recommended product approval for the company’s eye disease treatment (Eylea biosimilar) ‘Opuviz (ingredient name: aflibercept)’ in September this year. Therefore, if Obodence and Xbrick receive official approval, Sambaepis will secure a total of 11 biosimilar products in Europe.
“Through this European approval recommendation, we have once again proven our company’s global-level R&D capabilities,” said Byeong-in Jeong, head of the Regulatory Affairs (RA) team at Sambaepis. “We will be able to utilize biosimilars for more patients through our diverse product portfolio.” “We will do our best to provide an opportunity for treatment,” he said.
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, in October of last year, the clinical equivalence between SB16 and the original drug was confirmed by disclosing phase 1 and 3 clinical data through the annual academic conference of the American Society for Bone and Mineral Research (ASBMR).
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