Merck and Samsung Bioepis Form Biosimilars Development and Commercialization Agreement

Merck & Co. and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates, according to a Feb. 20, 2013, Merck press release.

“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, PhD, senior vice-president, biologics and vaccines research, Merck Research Laboratories, in the release. “We look forward to this collaboration and its potential to complement our expanding internal biologics portfolio.”

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 upfront payment from Merck, product supply income and will be eligible for additional payments associated with prespecified clinical and regulatory milestones. Further financial terms were not disclosed.

“Samsung Bioepis has been building the capabilities needed to develop high-quality biosimilars,” said Christopher Hansung Ko, PhD, CEO of Samsung Bioepis, according to the release. “With this development and commercialization agreement, Samsung takes a significant step toward becoming a major player in the biopharmaceutical industry.”