🇪🇺 AVZIVI in European Union

EMA authorised AVZIVI on 26 July 2024

Marketing authorisation

EMA — authorised 26 July 2024

  • Application: EMEA/H/C/005574
  • Marketing authorisation holder: FGK Representative Service GmbH
  • Local brand name: Avzivi
  • Indication: Treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer. first line treatment of patients with advanced and/or metastatic renal cell cancer.
  • Pathway: biosimilar
  • Status: approved

The European Medicines Agency (EMA) has approved AVZIVI, a biosimilar, for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, and recurrence of platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer. Additionally, AVZIVI has been approved for the first-line treatment of patients with unresectable advanced, metastatic, or recurrent non-small cell lung cancer and advanced and/or metastatic renal cell cancer. This approval was granted on 26 July 2024, under the expedited biosimilar pathway.

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AVZIVI in other countries

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

Other Other approved in European Union

Frequently asked questions

Is AVZIVI approved in European Union?

Yes. EMA authorised it on 26 July 2024.

Who is the marketing authorisation holder for AVZIVI in European Union?

FGK Representative Service GmbH holds the EU marketing authorisation.