Codes ATC:
L01FA01
Indication
Chronic lymphocytic leukaemia or small lymphocytic lymphoma
Code ICD11:
2B52.0
INN
Rituximab
Type de médicament
Biological agent
Type de liste
Liste complémentaire
Additional notes
Including quality-assured biosimilars
Formulations
Parenteral > General injections > IV:
100 mg per 10 mL in 10 mL vial ;
500 mg per 50 mL in 50 mL vial
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
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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.