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Legal Update

European Commission’s Update of Guideline on Duplicate Marketing Authorizations to Cover Biosimilars

30 May 2018
Mayer Brown Legal Update
On May 18, 2018, the European Commission ("Commission") launched a public consultation on "Duplicate Marketing Authorisation for Biological Medicinal Products" in relation to updating its Note on Handling of Duplicate Marketing Authorisation Applications ("Note on Duplicate MAs").

The Commission wants to learn about the potential impact of duplicate marketing authorizations for "friendly" biosimilars, i.e., biosimilars developed by the innovators of the reference biological medicinal products. Comments are due by September 10, 2018.


  • Geneviève Michaux
    T +32 2 502 5517
  • Luca Salernitano
    T +32 2 251 5957
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