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Argentina approves bevacizumab similar biological medicine Zutrab Posted 26/03/2021

The Argentina-based Richmond Laboratory (Laboratorios Richmond) announced on 19 March 2021 that it had gained approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) for its similar biological medicine (medicamento biológico similar) Zutrab (bevacizumab).

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Richmond Laboratories carried out a phase I clinical trial Zutrab evaluating the pharmacokinetic and safety profile of Zutrab compared to Avastin and Cizumab (a ‘similar biologic’), to establish similarity.

Richmond Laboratories says that Zutrab is the first similar biological medicine from the company’s oncology line and is the result of a biotechnology project that began several years ago. In its communication with the National Securities Commission, the company said that, in the medium term, this project will include the launch of new biotechnological products, with clinical studies being carried out in the country. In addition, the company added that it expects to continue its expansion in this area.

Zutrab is a similar biological medicine of Roche’s Avastin (bevacizumab), which also has a presence in the Argentinian market. There are two other bevacizumab similar biological medicines approved in Argentina, Bevax and Lumiere, which are both produced by Elea Laboratory (Laboratorio Elea) [1].

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘similar biological therapeutics’ approved in Argentina and ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related article
Argentinian guidelines for similar biological medicines

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America

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Source: ClinicalTrials.gov, Richmond Laboratories

Comments (3)

API Source posted 15/04/2021 - by Josef M.

Dear Gabriel This API is from Hetero Labs, and Indian company, FDA issued repeated warning letters to this manufacturer. https://www.biopharmadive.com/news/fda-hits-yet-another-indian-drugmaker-with-warning-letter/504016/ Best Josef.

Source of API?? posted 29/03/2021 - by Gabriel

I would like to know source of API? where is the comparability excercise and clinical trial published??

Serious scientific setback posted 27/03/2021 - by CAEME

We are very surprised by this approval of a product that clearly cannot be called Biosimilar. It is a substandard product that has been rejected by various regulatory agencies worldwide and Latin America. In the case of Colombia, they published that the product has serious quality flaws and its safety and efficacy profile cannot be assured. Lastly, the manufacturing site in India has been questioned multiple times by the FDA. I am sincerely concerned about the health using this product.

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