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Legal Update

FDA Issues Highly Anticipated Draft Guidance on Biosimilars

10 February 2012
Mayer Brown Legal Update
The US Food and Drug Administration has issued three draft guidance documents regarding biosimilars (a/k/a follow-on biologics). The documents describe key scientific and regulatory factors involved in submitting applications for biosimilar products for agency approval (351(k) applications). We review the key elements of each and provide links to the full text of the three guidance documents.


  • Joseph A. Mahoney
    T +1 312 701 8979
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