Generic Drugmakers Get Boost as FDA Move Helps Complex Copycats

  • Complex drugs are valuable to industry given higher prices
  • Agency proposal to increase competition of birth-control patch

Photographer: Dhiraj Singh/Bloomberg

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The U.S. Food and Drug Administration will make it easier for pharmaceutical companies to bring more complex -- and more profitable -- generic drugs to market, throwing the struggling industry a crucial lifeline.

Unlike relatively simple pills, drugs that combine a medicine with a delivery device can be harder to copy and therefore often don’t have generic competition. For manufacturers that do the extra work required to bring such products to market, they can be more profitable. But regulatory hurdles have made getting them approved more difficult, FDA Commissioner Scott Gottlieb said Tuesday, at a time when generic drug manufacturers such as Mylan NV and Teva Pharmaceutical Industries Ltd. are hurting.