Argentina approves bevacizumab similar biological medicine Zutrab

Biosimilars/News | Posted 26/03/2021 post-comment3 Post your comment

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).

Biological large Hanyang Univ V15c13

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 medicines’ 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


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

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

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Source:, Richmond Laboratories

comment icon Comments (3)
Post your comment
Posted 15/04/2021 by Josef M.
API Source

Dear Gabriel

This API is from Hetero Labs, and Indian company, FDA issued repeated warning letters to this manufacturer.


Posted 29/03/2021 by Gabriel
Source of API??

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

Posted 27/03/2021 by Unknown
Serious scientific setback

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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