🇪🇺 Trastuzumab biosimilar in European Union

EMA authorised Trastuzumab biosimilar on 12 December 2018

Marketing authorisations

EMA — authorised 12 December 2018

  • Application: EMEA/H/C/004916
  • Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
  • Local brand name: Ogivri
  • Indication: Breast cancer Metastatic breast cancer Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments in combination with paclitaxel for the treatment of those p
  • Pathway: biosimilar
  • Status: approved

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EMA

  • Application: EMEA/H/C/004346
  • Marketing authorisation holder: Mylan S.A.S.
  • Local brand name: Ogivri
  • Pathway: biosimilar
  • Status: withdrawn

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Trastuzumab biosimilar in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Trastuzumab biosimilar approved in European Union?

Yes. EMA authorised it on 12 December 2018; EMA has authorised it.

Who is the marketing authorisation holder for Trastuzumab biosimilar in European Union?

Biosimilar Collaborations Ireland Limited holds the EU marketing authorisation.