Merck and Samsung Bioepis enter biosimilars development and commercialization agreement

February 21, 2013 9:20 AM

Merck, known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd., entered into an agreement to develop and commercialize multiple pre-specified and undisclosed biosimilar candidates.

“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 vice president, biologics and vaccines research, Merck Research Laboratories. “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 pre-specified 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, 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.”

Merck’s interest in biosimilars started back in 2008 when they were planning to invest $1.5 billion in this business. Their first project, the biosimilar version of Aranesp was dropped in 2010. In 2011, they made a deal with Korea’s Dong-A Pharmaceuticals for developing the biosimilar of Enbrel but following the patent extension of Amgen, Merck left the project and cancelled the deal.

Samsung Bioepis is a joint venture between Korea’s Samsung Biologics and Biogen Idec Inc. of USA. Biogen Idec makes biologic medicines including Rituxan, for rheumatoid arthritis and non-Hodgkin’s lymphoma, and Avonex, for multiple sclerosis.


Source: Merck press release

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