INCHEON, Korea, April 05, 2024).
"We are thrilled to announce the initiation of Phase 3 clinical trial for SB27, after our successful Phase 1 clinical trial initiation in February 2024," said Ilsun Hong, Vice President, Product Evaluation Team Leader of Samsung Bioepis. "Based on our extensive clinical trial experience accumulated over the years, we will work closely with study investigators to ensure successful completion of the clinical trials for SB27."
As of April 2024, Samsung Bioepis has eight biosimilars approved and seven available around the worldiii - SB4 (etanercept), SB2 (infliximab), SB5 (adalimumab), SB3 (trastuzumab), SB8 (bevacizumab), SB11 (ranibizumab), SB12 (eculizumab), and SB15 (aflibercept)iv - along with three biosimilar candidates in pipeline - SB16 (denosumab), SB17 (ustekinumab) and SB27 (pembrolizumab).v
About Samsung Bioepis Co., Ltd.
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.comand follow us on social media - LinkedIn, X.
i KEYTRUDA is a trademark of Merck Sharp & Dohme Corp.
ii The countries of recruitment include Bosnia and Herzegovina, Brazil, Georgia, Germany, India, Japan, Malaysia, Mexico, Philippines, Romania, Serbia, Spain, Thailand, and Turkey.
iii "Approval" and "Availability" signify regulatory approval/launch in one or more markets and do not necessarily indicate approval/launch in all markets worldwide.
iv SB15 (aflibercept) is approved in Korea by the Ministry of Food and Drug Safety (MFDS) and is not yet available in the market.
v In the United States, the Biologics License Application (BLA) for SB17 is under review by the U.S. Food and Drug Administration (FDA). In Europe, SB17 has been recommended for approval by the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP), having received positive CHMP opinion in February 2024.
