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Merck, Samsung JV team up on biosimilar medicines

Published on NewsOK Modified: February 20, 2013 at 2:39 pm •  Published: February 20, 2013

None are on the market yet in the U.S, where just last year the Food and Drug Administration produced regulations on how biosimilars can be approved.

Biosimilar drugs are expected to be somewhat cheaper than the original versions, but nowhere near the 50 percent to 80 percent off common with generic pills. That's due to the costly additional testing needed for approval, compared with generic pills, and the much more expensive manufacturing process.

Merck already makes a few biologic medicines, including drugs to treat hepatitis B and C, an infertility treatment and its genetically engineered Gardasil vaccine against a sexually transmitted virus, HPV, that causes several types of cancer and genital warts.

The company, based in Whitehouse Station, N.J., has said it's developing an experimental biosimilar version of rituximab, an antibody-based biologic drug sold under brand names including Rituxan.

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


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