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Samsung Bioepis Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)

INCHEON, Korea, April 05, 2024 (Korea Bizwire) – Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB27, the company’s proposed biosimilar referencing Keytrudai (pembrolizumab). The Phase 3 clinical trial for SB27 is a randomized, double-blind, parallel group, multicenter studyii to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda [...]

Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate

Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America Partnership to support Samsung Bioepis pipeline expansion and provide increased access to biosimilars INCHEON, Korea, Sept. 11, 2023 (Korea Bizwire) – Samsung Bioepis Co., Ltd. today announced that it has entered into a commercialization agreement with Sandoz for SB17, [...]

Samsung Bioepis Said to Acquire U.S. Biogen’s Biosimilar Unit

SEOUL, Aug. 2 (Korea Bizwire) — Samsung Bioepis Co., a biosimilar medicine developer under Samsung Group, has been in talks with Biogen Inc. to buy the U.S. biotech firm’s biosimilar business unit, industry sources said Wednesday. Through the deal with the Nasdaq-listed firm, Samsung Bioepis seeks to secure a direct sales network in the United [...]

Samsung Bioepis Releases 2023 Sustainability Report

INCHEON, Korea, June 30 (Korea Bizwire) — Samsung Bioepis Co., Ltd. today released its 2023 sustainability report, highlighting its progress toward building more sustainable and socially responsible practices in research and development (R&D), clinical trials, manufacturing, and supply chain management. “The consequences of the COVID-19 pandemic such as global supply chain disruptions, as well as [...]

Samsung Bioepis Releases its First US Biosimilar Market Report, Providing Insights on Pricing Trends and Usage Across Molecules

INCHEON, Korea, April 17 (Korea Bizwire) — Samsung Bioepis Co., Ltd. today released the first edition of its Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the United States. The first quarterly report details the most recent price trends of all molecules for which biosimilars have launched, along with [...]

Samsung Bioepis Wins ‘Company of the Year, Asia-Pacific’ Award at the Global Generics & Biosimilars Awards 2022

INCHEON, Korea, Nov. 3 (Korea Bizwire) — Samsung Bioepis Co., Ltd. announced the company has won ‘Company of the Year, Asia-Pacific’ at the ‘Global Generics & Biosimilars Awards 2022’ held on November 2, 2022 in Frankfurt, Germany. “It is an honor to receive a prestigious ‘Company of the Year, Asia-Pacific’ award and to be recognized [...]

Samsung Bioepis Obtains Two ISO Certifications for Environmental Management System and Energy Management System

INCHEON, Korea, Sept. 14 (Korea Bizwire) — Samsung Bioepis Co., Ltd. today announced that it has attained two ISO certifications: ISO 140001 (Environmental Management System) and ISO 50001 (Energy Management System) from Lloyd’s Register Quality Assurance (LRQA), reflecting the company’s ongoing practices and commitment to becoming a sustainable company. “We are delighted to obtain the [...]

Samsung Bioepis’ Biosimilar Candidate SB12 Under Approval Review in Europe, S. Korea

SEOUL, July 20 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. was in the process of acquiring regulatory approval from European and South Korean drug authorities for SB12, a paroxysmal nocturnal hemoglobinuria (PNH) treatment biosimilar candidate, industry sources said Wednesday. The company has submitted approval applications for SB12, a more affordable version of [...]

Samsung Biologics Completes Acquisition of Biogen’s Entire Stake in Samsung Bioepis

SEOUL, April 20 (Korea Bizwire) — Samsung Biologics Co., the biotech arm of South Korea’s Samsung Group, said Wednesday it has completed the first payment to acquire the U.S. drugmaker’s entire stake in Samsung Bioepis. Earlier, Samsung Biologics reached a deal with Biogen to purchase the U.S. drugmaker’s entire stake in Samsung Bioepis for US$2.3 [...]

Health Canada Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab)

INCHEON, Korea and TORONTO, March 10 (Korea Bizwire) — Samsung Bioepis Co., Ltd. and Biogen Canada Inc. today announced that Health Canada has approved BYOOVIZ™ – a biosimilar referencing LUCENTIS®i (ranibizumab) – for the treatment of neovascular (wet) age-related macular degeneration (AMD); visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), [...]