Export

ATC codes: L01XC03
Indication
Carcinoma of breast, specialised type ICD11 code: 2D10
INN
Trastuzumab
Medicine type
Biological agent
List type
Complementary 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
EML status history
First added in 2015 (TRS 994)
Changed in 2019 (TRS 1021)
Sex
All
Age
Adolescents and adults
Therapeutic equivalence
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
Tags
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.