Merck entered into an agreement with Samsung Bioepis to develop and commercialize multiple prespecified and undisclosed biosimilar candidates. Samsung Bioepis, which is a joint venture formed last year by Samsung Biologics and Biogen Idec to focus on biosimilars, has a R&D center based in Song-do Incheon, Korea.
Under the agreement, Samsung Bioepis will be responsible for preclinical and clinical development, process development and manufacturing, clinical trials, and registration. Merck will be responsible for commercialization. Samsung Bioepis will receive an up-front payment from Merck, product supply income, and will be eligible for additional payments associated with prespecified clinical and regulatory milestones.
“The combination of Merck’s global commercial presence with Samsung Bioepis’ biologic development and manufacturing capabilities positions the two companies well to increase access to biosimilars to improve human health,” said Rich Murray, Ph.D., senior vp, biologics and vaccines research, Merck Research Laboratories.
“Samsung Bioepis has been building the capabilities needed to develop high-quality biosimilars,” added Christopher Hansung Ko, Ph.D., CEO of Samsung Bioepis. “With this development and commercialization agreement, Samsung takes a significant step toward becoming a major player in the biopharmaceutical industry.”