🇪🇺 CT-P16 in European Union

EMA authorised CT-P16 on 10 November 2017

Marketing authorisations

EMA — authorised 10 November 2017

  • Application: EMEA/H/C/004360
  • Marketing authorisation holder: Amgen Europe B.V.
  • Local brand name: Kyomarc
  • Indication: Treatment of breast cancer, non-small cell lung cancer, renal cell cancer, advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, platinum-sensitive epithelial ovarian, fallopian tube or primary
  • Status: withdrawn

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EMA — authorised 19 August 2020

  • Application: EMEA/H/C/005106
  • Marketing authorisation holder: Samsung Bioepis NL B.V.
  • Local brand name: Aybintio
  • Indication: Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1 of the SmPC. Aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options includin
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 24 September 2020

  • Application: EMEA/H/C/005181
  • Marketing authorisation holder: Centus Biotherapeutics Europe Limited
  • Local brand name: Equidacent
  • Indication: Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including t
  • Pathway: biosimilar
  • Status: withdrawn

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EMA — authorised 11 January 2021

  • Application: EMEA/H/C/005640
  • Marketing authorisation holder: Samsung Bioepis NL B.V.
  • Local brand name: Onbevzi
  • Indication: Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or an
  • Pathway: biosimilar
  • Status: withdrawn

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EMA — authorised 26 March 2021

  • Application: EMEA/H/C/005556
  • Marketing authorisation holder: STADA Arzneimittel AG
  • Local brand name: Oyavas
  • Indication: Oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthr
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 21 April 2021

  • Application: EMEA/H/C/005327
  • Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
  • Local brand name: Abevmy
  • Indication: Abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthr
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 27 May 2024

  • Application: EMEA/H/C/005723
  • Marketing authorisation holder: Outlook Therapeutics NL B. V.
  • Local brand name: Lytenava
  • Indication: Lytenava is indicated in adults for treatment of neovascular (wet) age-related macular degeneration (nAMD).
  • Status: approved

The European Medicines Agency (EMA) granted marketing authorisation for Lytenava (CT-P16) on 27 May 2024. Lytenava is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD) in adults. This authorisation was granted to Outlook Therapeutics NL B. V., the marketing authorisation holder.

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EMA

  • Application: EMEA/H/C/005611
  • Marketing authorisation holder: Mylan IRE Healthcare Limited
  • Local brand name: Lextemy
  • Indication: Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
  • Pathway: biosimilar
  • Status: withdrawn

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EMA

  • Application: EMEA/H/C/005433
  • Marketing authorisation holder: Rotterdam Biologics B.V.
  • Local brand name: Ipique
  • Indication: Treatment of neovascular (wet) age-related macular degeneration (AMD)
  • Status: rejected

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Other Oncology approved in European Union

Frequently asked questions

Is CT-P16 approved in European Union?

Yes. EMA authorised it on 10 November 2017; EMA authorised it on 19 August 2020; EMA authorised it on 24 September 2020.

Who is the marketing authorisation holder for CT-P16 in European Union?

Amgen Europe B.V. holds the EU marketing authorisation.