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ATC codes: L01FA01
Indication
Follicular lymphoma ICD11 code: 2B50.Z
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
EML status history
First added in 2015 (TRS 994)
Changed in 2019 (TRS 1021)
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
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Wikipedia
DrugBank
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.