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6 Jan 2017

USFDA Biosimilar Approval : 4 Biosimilar total and 3 new approval of biosimilar in 2016

  • Tilldate there are 4 Biosimilar approved in US.
  • In 2015, USFDA approved first Biosimilar
  • In year 2016, there are 3 new biosimilar approval
US approval Year of Approval Biosilimar Brand Company Biomolecule Reference Product Company
1st Biosimilar 2015 Zarxio Sandoz Filgrastim Neupogen Amgen
2nd Biosimilar 2016 Inflectra Celltrion Infliximab Remicade Janssen Biotech
3rd Biosimilar 2016 Erelzi Sandoz Etanercept Enbrel Amgen
4th Biosimilar 2016 Amjevita Amgen Adalimumab Humira AbbVie

HAVE ALL 4 BIOSIMILAR APPROVED IN US, APPROVED IN EU?

EU and USFDA have different look out for BIOSIMILAR or Similar Biologics approval process.

  • Two of the four biosimilars approved in the U.S., Sandoz’s biosimilar of Amgen’s Enbrel and Amgen’s biosimilar of AbbVie’s Humira, were approved in the U.S. without any prior approval in Europe.
  • Sandoz’s application for its biosimilar of Enbrel is pending before the EMA.
  • Amgen’s application for its biosimilar of Humira is also pending in EMA.

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