🇪🇺 Trastuzumab Biosimilar ABP 980 in European Union

EMA authorised Trastuzumab Biosimilar ABP 980 on 26 July 2018

Marketing authorisation

EMA — authorised 26 July 2018

  • Application: EMEA/H/C/004463
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Trazimera
  • Indication: Breast cancer Metastatic breast cancer Trazimera 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
  • Pathway: biosimilar
  • Status: approved

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Frequently asked questions

Is Trastuzumab Biosimilar ABP 980 approved in European Union?

Yes. EMA authorised it on 26 July 2018.

Who is the marketing authorisation holder for Trastuzumab Biosimilar ABP 980 in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.