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April 1, 2015

View Archives Issues

  • FDA Greenlights Biosimilars

    In one of the most important decisions of the past 5 years, the FDA has given the greenlight to the first biosimilar drug with the approval of Sandoz’s filgrastim-sndz, a copy of Amgen’s multibillion dollar drug filgrastim (Neupogen). Biosimilars are drugs that are derived from living organisms and thus cannot be exact copies of the original compounds. They are different from generics in this respect. But the FDA has agreed to approve biologic copies that are “highly similar to another, already FDA-approved biologic (known as the reference product).”