12/9/2011

By the end of this year, the FDA is set to issue a pathway for the approval of generic forms of biological drugs. However, even though the generic biologics, termed biosimilars, will cost less than brand-name biologics, keeping costs down won't be easy, because the manufacturing process of biologics is inherently more complicated than that of other pharmaceuticals. The FDA's biotechnology products office is hoping that the evolution of better analytical tools will make it easier for the agency to verify that biosimilars are structurally and functionally similar to their brand-name counterparts.

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