Samsung Bioepis Receives Positive CHMP Opinion for Eculizumab Biosimilar, EPYSQLI
2023-03-31
临床3期临床结果上市批准
INCHEON, Korea I March 31, 2023 I Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EPYSQLI™, a biosimilar referencing Soliris 2(eculizumab), also known as SB12.
EPYSQLI™ has been recommended for approval for the treatment of adult and children patients with paroxysmal nocturnal hemoglobinuria (PNH).
“We are pleased to see EPYSQLI becoming our first biosimilar in hematology to be recommended for approval in Europe. This marks another significant milestone for Samsung Bioepis and more importantly for people living with PNH,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “We will continue our work to transform the way biologic therapies are brought to patients and enhance the lives of patients, including those with rare diseases, through our pioneering and innovative use of science and technology,” she added.
The CHMP’s positive opinion on EPYSQLI™ was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-blind, multicenter, cross-over Phase 3 study of SB12 demonstrated equivalent clinical efficacy of SB12 and reference eculizumab by evaluating lactate dehydrogenase (LDH) in PNH patients, indicating that the SB12 was bioequivalent to the reference eculizumab.
This CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant a marketing authorization for EPYSQLI™. If a marketing authorization is granted by the EC, EPYSQLI™ would become Samsung Bioepis’ first hematology biosimilar, further expanding the company’s biosimilars portfolio.
About the SB12 Phase 3 study
The study is a randomized, double-blind, multicenter, cross-over study in 50 patients to treatment sequence I (TS1: SB12 to reference eculizumab, n=25) or treatment sequence II (TS2: reference eculizumab to SB12, n=25). Patient received 600 mg of SB12 (TS1) or reference eculizumab (TS2) intravenously every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter (maintenance phase). The treatment was switched to reference eculizumab (TS1) or SB12 (TS2) at Week 26, and switched treatment was provided until Week 50.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.
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1 Soliris is a registered trademark of Alexion Pharmaceuticals, Inc.
2 European Medicines Agency. Soliris Product Information. Available at https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf [Accessed March 2023]
SOURCE: Samsung Bioepis
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