Codes ATC:
L01FD01
Indication
Carcinoma of breast, specialised type
Code ICD11:
2D10
INN
Trastuzumab
Type de médicament
Biological agent
Type de liste
Liste complémentaire
Additional notes
Including quality-assured biosimilars
Formulations
Parenteral > General injections > IV:
60 mg in vial powder for injection ;
150 mg in vial powder for injection ;
440 mg in vial powder for injection
Historique des statuts LME
Sexe
Tous
Âge
Adolescents et adultes
Équivalence thérapeutique
La recommandation concerne ce médicament spécifique
Renseignements sur le brevet
Main patents have expired but secondary patents might remain active in some jurisdictions. For more
information on specific patents and license status for developing countries visit www.MedsPal.org
Lire la suite
sur les brevets.
Résumé des preuves et recommandation du comité d'experts
The Committee noted the correspondence from the European Society for Medical Oncology (ESMO) requesting recognition of biosimilars of rituximab and trastuzumab on the EML. The Committee agreed that quality-assured biosimilars of these monoclonal antibodies represent an opportunity for expanding affordable access to cancer medicines for health systems. To help improve access, the Committee recommended the current listing for intravenous rituximab on the EML should indicate that quality-assured biosimilars of rituximab should also be considered as essential medicines. In addition, the Expert Committee recommended that WHO continue to facilitate access to biosimilars through the Prequalification programme and WHO Collaborative Registration Procedure.