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Regulatory requests in procedure of issue marketing authorisation for biosimilars

  • At: 2012 FIP Congress in Amsterdam (the Netherlands)
  • Type: Poster
  • By: TUBIC, Biljana (Agency for Medicines and Medical Devices, Department for medicines, Banja Luka, Bosnia and Herzegovina)
  • Co-author(s): Grubisa, N.G. (Agency for Medicines and Medical Devices, Banja Luka, Bosnia and Herzegovina)
  • Abstract:

    I. A biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the


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Last update 4 October 2019

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