1. Notification procedures
  2. Commercialisation medicinal GMOs
  3. Commercialisation of GMO medicinal products: Some figures

Commercialisation of GMO medicinal products: Some figures

GMO medicinal products for human use

The first application for authorisation for the placing on the market of a medicinal product for human use consisting of a GMO was filed with the EMA in 2005. This dossier related to a recombinant adenovirus developed to treat cancers. Other dossiers have been submitted since then and examined by the Biosafety Advisory Council as part of the Member State consultation procedure.

Start of procedure Treatment type GMO type
2005 Treatment against cancer GM adenovirus
2007 Treatment against cancer GM adenovirus
2008 Treatment against cancer GM adenovirus
2008 Treatment against cancer GM adenovirus
2008 Anti-flue vaccine Attenuated influenza virus
2010 Treatment of rare human genetic disorder GM adenovirus
2014 Treatment against cancer GM T-cells with retrovirus
2015 Anti-flue vaccine​ Attenuated influenza virus
2015 Treatment of severe immunodeficiency CD34+ cells transduced with retrovirus
2016 Dengue vaccine Attenuated GM virus
2017 Treatment of vision loss GM adeno-associated virus
2017 Treatment of lymphoma Autologous cell therapy
2017 Treatment against cancer Autologous cell therapy
2018 Treatment against cancer GM bacteria
2018 Treatment against beta-thalassemia Autologous cell therapy

​Table: GMO medicinal products for human use - Dossiers submitted at European level and assessed by the Biosafety Advisory Council

Nine products have been granted a marketing authorisation in the EU so far (for more details on the product and the authorisation procedure click on the corresponding link):

  • Fluenz (27/01/2011) - withdrawn on 03/12/2014 and replaced by Fluenz Tetra (04/12/2013)
  • Glybera (25/10/2012)
  • Imlygic (16/12/2015)
  • Zalmoxis (18/08/2016)
  • Strimvelis (26/05/2016)
  • Kymriah (22/08/2018)
  • Yescarta (23/08/2018)
  • Luxturna (22/11/2018)
  • Zynteglo (29/05/2019)

GMO medicinal products for veterinary use

Up to now, nineteen GMO medicinal products for veterinary use have been granted a marketing authorisation in the EU. Sixteen of these products are vaccines, one is a treatment against cancer (Oncept IL-2).
Two of them were authorised under Directive 90/220/EEC:

  • A vaccine against the porcine Aujeszky disease (genetically modified virus), authorised in December 1992 (authorisation amended in July 1994 – Decision 94/505/EC – to cover a new form of administration);
  • The Raboral recombinant vaccine for preventing rabies in foxes (see text box on the right), authorised in October 1993 (Decision 93/572/EEC).

The other products have been processed under Regulation (EEC) No. 2309/93 (between 1993 and 2004) or under Regulation (EC) 726/2004.

All these GMO medicinal products for veterinary use are listed below in alphabetical order with the corresponding date of authorisation. For more details on the product and the authorisation procedure click on the corresponding link.