Merck Wants To Develop Follow-On Biologics

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biologics-costThe drugmaker is hosting its annual R&D briefing for Wall Street analysts and fund managers, where surprises are usually not on display. This time, however, Merck execs are saying they want to establish a new unit to make generic biotechs, which some calls biogenerics, biosimilars or follow-on biologics, although there are subtle differences between these terms.

In any event, the basis for the effort is Merck’s acquistion of GlycoFi, a biotech bought two years ago for its proprietary glyco-engineering technology. The move represents what Merck execs are caling a “significant” opportunity since so patents on so many big-selling biologies are scheduled to expire through 2017. Merck’s first follow-on biologic is for anemia, with plans to in 2012, and another five candidates are hoped to be in late-stage development by then (see Merck statement).

“We believe we can become the leading provider of high quality, competitively priced follow-on biologics,” Merck ceo Dick Clark says. The arrival of the Obama administration and renewed enthusiasm on Capitol Hill for legislation that could create an easier path for generic biotech medicines may help Merck’s cause.

Of course, the possibility that Congress will finally give the FDA a green light to create a so-called pathway for developing follow-on biologics is more likely, since President-elect Barack Obama made a point of saying he supports such a move as a way to lower health care costs (back story). For now, though, Merck chief scientist Peter Kim says his strategy assumes it will not be possible anytime soon to pursue biosimilars.

Separately, Merck plans to push for expanded use of its Isentress AIDS med and the Gardasil vaccine next year. In particular, the drugmaker will seek FDA approval to market the Gardasil HPV vaccine for women up to 45 years old and…men.

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  1. If you think that glyco-engineering is a winning strategy, read the history of Neose Technologies, wich is in the process of liquidating its assets.

  2. Glyco-engineering or no, this is a great strategy for large pharma to build up expertise in biologic development. It’s an area where Merck, et. al, can compete with Teva, et. al., without cannibalizing their own core business.

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