ATC codes:
L01FA01
Indication
Chronic lymphocytic leukaemia or small lymphocytic lymphoma
ICD11 code:
2B52.0
INN
Rituximab
Medicine type
Biological agent
List type
Complementary
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
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
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
Read more
about patents.
Summary of evidence and Expert Committee recommendations
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.