Regulations for the registration of biological products were implemented in Venezuela in 2000, making them formally distinct from those for small molecule products.

Bioterapéuticos similares are defined in Venezuela as biotechnology-derived drugs that are similar in terms of quality, safety and efficacy to their reference biotherapeutic products.

Until now regulations in Venezuela have considered that all biological products are new and there has been no distinct regulatory pathway for bioterapéuticos similares.

The proposed draft guideline aims to facilitate the registration of bioterapéuticos similares in Venezuela through an abbreviated pathway.

Guideline for registration and pharmacovigilance of bioterapéuticos similares
Date: 12 June 2012
http://www.inhrr.gob.ve/pdf/rc_pdf/proyecto_de_norma_PBS.pdf

The proposed draft guideline covers well-defined and characterized biotechnology products, i.e. drugs whose active ingredient are therapeutic proteins derived from recombinant DNA or monoclonal antibodies. Vaccines, plasma products and other biological products whose preparation does not involve genetic manipulation are excluded from the scope of the guideline.

The proposed draft guideline does not allow for extrapolation of indications, with comparability studies for each separate indication required.

The draft guideline has been released for public consultation and feedback should be sent to the INHRR via divcnpb@inhrr.gob.ve and proyectodenormaPBS@gmail.com. Comments on the draft guideline will be accepted until 13 December 2013.

Editor’s comment
It should be noted that bioterapéuticos similares approved in Venezuela might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA 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. 

If you would like to receive a copy* of the proposed draft guideline, please email us.

^{*For profit organizations subjected to a fee}

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Regulation of similar biotherapeutic products in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Dec 6]. Available from: www.gabionline.net/Biosimilars/Research/Regulation-of-similar-biotherapeutic-products-in-Latin-America

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