Merck, Samsung JV team up on biosimilar medicines

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Associated Press

Posted on February 20, 2013 at 6:01 PM

Updated Wednesday, Feb 20 at 6:01 PM

TRENTON, N.J. (AP) — Drugmaker Merck & Co. said Wednesday it will partner with a Korean joint venture company to develop and market multiple biosimilar drugs, which are like generic versions of expensive biologic drugs.

It's the latest move in the company's efforts to develop original and biosimilar biologic drugs.

Merck, the world's third-biggest drugmaker by revenue, said it's entered an agreement to work with Samsung Bioepis Co. Ltd. of Seoul, Korea, to produce "pre-specified" biosimilars. The companies aren't disclosing the individual biologic drugs they are targeting.

Samsung Bioepis, which has both biologic drug research and manufacturing capabilities, will handle all steps from laboratory and human testing of potential biosimilar drugs through getting them approved by government regulators. Merck, which operates in more than 140 countries, will handle marketing of any medicines approved.

Financial terms of the deal were not detailed, but Samsung Bioepis will get an upfront payment from Merck and payments for meeting milestones in testing and seeking approval for any drugs. Merck, the maker of blockbuster Type 2 diabetes drug Januvia, will then buy any finished products from its partner and resell them around the world.

"We look forward to this collaboration and its potential to complement our expanding internal biologics portfolio," Rich Murray, head of biologics and vaccine research at Merck Research Laboratories, said in a statement.

In late afternoon trading, Merck shares rose 40 cents to $42.62.

Biosimilars are medicines that are similar, but not quite identical, to older biologic drugs — injectable medicines that are "manufactured" in living cells rather than by mixing chemicals together in vats to create traditional pills.

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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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

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