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Which brands of asparaginase are substandard?

An investigation by the Bureau of Investigative Journalism has revealed serious concerns about poor-quality brands of a particular cancer drug spreading around the world. The drug, called asparaginase, is a crucial treatment for patients with acute lymphoblastic leukaemia (ALL), the most common kind of childhood cancer.

The Bureau found that at least a dozen brands of asparaginase have been proven to be poor quality, with ten still on the market. In some cases brands fell well below the standard needed to treat cancer. Many have also been found to contain contaminants such as bacteria that could be harmful to patients.

In the past five years these brands have been shipped to more than 90 countries. Experts estimate 70,000 children around the world are at risk. We are publishing the names of these brands and their manufacturers/suppliers in the table. You can read the Bureau’s full investigation here.

There is more detail of the research into substandard asparaginase in the scientific papers listed below the table.

Name of asparaginase product Manufacturer/supplier
Asginase* Sun Pharmaceutical Industries
Aspatero Hetero Healthcare
Bionase Zydus
Celginase Celon Laboratories
Ecaspar* Beijing SL Pharmaceutical
L-Aspase Miracalus/Naprod Life Sciences
L-Ginase Getwell Oncology
Lagicad Cadila
Leuginase* Beijing SL Pharmaceutical
Leucoginase VHB Medi Sciences
Oncoginase Chandra Bhagat Pharma
Onconase United Biotech
Pegapar Virchow Biotech

* No longer manufactured

Sun Pharmaceuticals told the Bureau that it does not currently manufacture or market Asginase, and the product was discontinued in 2019.

Beijing SL Pharmaceutical told the Bureau that it has produced asparaginase for a dozen countries over the past decade, and had never received reports of quality concerns bar those from Brazil. The company said its asparaginase is tested by Chinese drug regulators and in-house, where — they claimed — results have stayed within statutory limits over the past decade.

Hetero Healthcare, Zydus, Celon Laboratories, Miracalus, Naprod Life Sciences, Getwell Oncology, Cadila, VHB Medi Sciences, Chandra Bhagat Pharma, United Biotech and Virchow Biotech did not respond to requests for comment.

Bibliography

Zenatti PP et al. 2018. Low Bioavailability and High Immunogenicity of a New Brand of E. coli L-Asparaginase with Active Host Contaminating Proteins. EBioMedicine. 30:158–166.

Cecconello DK et al. 2018. Monitoring asparaginase activity in middle-income countries. Lancet Oncol. 19(9):1149–1150.

Sankaran H et al. 2020. A comparison of asparaginase activity in generic formulations of E.coli derived L- asparaginase: In-vitro study and retrospective analysis of asparaginase monitoring in pediatric patients with leukemia. Br J Clin Pharmacol. 86(6):1081–1088.

Battistel AP et al. 2021. Allergic reactions to asparaginase: retrospective cohort study in pediatric patients with acute lymphoid leukemia. Hematol Transfus Cell Ther. 43(1):9–14.

Sidhu J et al. 2021. Unsatisfactory quality of E. coli asparaginase biogenerics in India: Implications for clinical outcomes in acute lymphoblastic leukaemia. Pediatr Blood Cancer. 68(11):e29046.

Michalowski MB et al. 2021. Influence of different asparaginase formulations in the prognosis of children with acute lymphocytic leukaemia in Brazil: a multicentre, retrospective controlled study. Br J Haematol. 194(1):168–173.

Matteo C et al. 2022. Pharmacological and clinical monitoring in children with acute lymphoblastic leukemia treated with a biogeneric PEG-L-asparaginase product. Pediatr Blood Cancer. 69(9):e29753.

Reporters: Rosa Furneaux and Laura Margottini
Additional reporting: J
ill Langlois, Benjamín Miranda, Sam Horti and Ben Stockton
Illustrations: Evangeline Gallagher
Global health editor: Chrissie Giles
Global editor: James Ball
Editor: Meirion Jones
Production editor: Frankie Goodway
Fact checker: Lowri Daniels
Impact producer: Paul Eccles

This article is part of our Global Health project, which has a number of funders including the Bill & Melinda Gates Foundation. None of our funders have any influence over the Bureau’s editorial decisions or output.