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Merck, Samsung to Collaborate on Biosimilars

Vaccination (U.S. Army Corps of Engineers)

(U.S. Army Corps of Engineers)

The pharmaceutical company Merck & Co. in New Jersey and Samsung Bioepis Co. in Seoul, South Korea agreed on a deal for licensing and taking to market non-branded biologic therapies called biosimilars. While the companies released an outline of the financial arrangements, the dollar amount of the agreement was not disclosed.

Biosimilars are treatments and vaccines created from living cells, such as genetically engineered proteins, and made to work like first-generation biologics for which patents have expired or are soon to expire. Biosimilars are more complex than chemically derived drugs, and unlike generic forms of these drugs, biosimilars are sometimes not molecularly identical to the original therapies. FDA issued its draft guidance on regulating biosimilars only about a year ago.

Under the agreement, Samsung Bioepis will conduct the preclinical research, process development and manufacturing, clinical trials, and registration of new products with regulatory authorities. Merck will be responsible for commercialization of the biosimilar products. Samsung Bioepis will receive an upfront payment from Merck along with product supply income. Samsung Bioepis will also be eligible for further payments tied to specified clinical and regulatory milestones.

Samsung Bioepis is a $300 million joint venture to produce biosimilars of Samsung Biologics and the Massachusetts biotechnology company Biogen Idec, formed in December 2011. Samsung owns an 85 percent stake in Samsung Bioepis, with Biogen Idec owning the remaining 15 percent.

Rich Murray, Merck’s vice-president for biologics and vaccines research, says the agreement will help build the company’s biologics portfolio. “The combination of Merck’s global commercial presence with Samsung Bioepis’s biologic development and manufacturing capabilities,” says Murray, “positions the two companies well to increase access to biosimilars to improve human health.”

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Hat tip: FirstWord Pharma

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