To make copycat drugs more competitive, FDA is taking a harder look at the originals

(Ref: CNBC)
  • The FDA wants drugmakers to improve biologic drugs in an effort to ease the development of biosimilars, CNBC reported Wednesday.

  • FDA Commissioner Scott Gottlieb explained that because biologics can change over time, biosimilars must be tested in more patients to prove that they have equivalent efficacy.

  • In this aim, the FDA wants drugmakers to use fewer variables in the manufacturing of branded biologics.

  • The FDA has approved nine biosimilars, the first of which was cleared in 2015.

  • "I think we will see a lot of biosimilar competition come onto the market and we will also see consumer and provider acceptance," Gottlieb stated.

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