Home / Biosimilars / General / Similar biotherapeutic products approved and marketed in Latin America

Similar biotherapeutic products approved and marketed in Latin America Posted 25/10/2013

Last update: 14 July 2017

Regulation of similar biotherapeutic products in Latin America varies widely among different countries and many countries have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products [1, 2].

For example, in recent years, ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) in Argentina, ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil and COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico have developed their own abbreviated regulatory pathways for similar biotherapeutic products, by merging World Health Organization (WHO) and European Medicines Agency (EMA) guidelines for biosimilars to suit their own political and economic needs [3].

On 21 January 2013, the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) also announced the release of a new draft guideline for biologicals, includingproductos bioterapéuticos similares(similar biotherapeutic products), in Colombia [4].

To date, similar biotherapeutic products for infliximab, rituximab and etanercept have been approved for marketing in Latin America, see Table 1.

Table 1: Similar biotherapeutic products approved and marketed in Latin America

Product name

Active substance

Therapeutic area

Countries marketed

Company

Latin American partner

Etanar

etanercept

Ankylosing spondylitis Arthritis
Psoriasis

Colombia

Shanghai CP Goujian

LaFrancol

Fiprima

filgrastim

Neutropenia

Brazil [5]

Eurofarma 
Laboratórios 

Not applicable

Kikuzubam

rituximab

Rheumatoid arthritis
Non-Hodgkin lymphoma
Leukaemia

Mexico

Probiomed

Not applicable

Novex

rituximab

Rheumatoid arthritis
Non-Hodgkin lymphoma
Leukaemia

Argentina

mAbxience

Laboratorio Elea

Reditux/ Tidecron

rituximab

Rheumatoid arthritis
Non-Hodgkin lymphoma
Leukaemia

Bolivia, Chile, Ecuador, Paraguay, Peru

Dr Reddy’s Laboratories

CF Recalcine (Chile)
Western Pharmaceutical (Ecuador)*
Farmindustria (Peru)*
FAPASA (Paraguay)

Remsima

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriasis
Psoriatic arthritis Rheumatoid arthritis
Ulcerative colitis

Brazil [6], Colombia [7], Venezuela [8]

Celltrion/ Hospira

Amarey Nova Medical 

approved via 'generics' pathway; *Western Pharmaceutical and Farmindustria are subsidiaries of CF Recalcine.

Editor’s comment
It should be noted that similar biotherapeutic products approved in Latin American countries might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. The EMA (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.

Related articles
Similar biotherapeutic products under development in Latin America

Biosimilars approved in Europe

References
1.  Mysler E, Scheinberg M. Biosimilars in rheumatology: a view from Latin America. Clin Rheumatol. 2012;31:1279-80.
2.  Desanvicente-Celis Z, Caro-Moreno J, Enciso-Zuluaga M, Anaya JM. Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases. Biosimilars. 2013;3:1-17.
3.  GaBI Online - Generics and Biosimilars Initiative. Regulation of similar biotherapeutic products in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available from: www.gabionline.net/Biosimilars/Research/Regulation-of-similar-biotherapeutic-products-in-Latin-America
4.   GaBI Online - Generics and Biosimilars Initiative. Colombia issues draft decree for registration of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available from: www.gabionline.net/Guidelines/Colombia-issues-draft-decree-for-registration-of-biologicals
5.   GaBI Online - Generics and Biosimilars Initiative. Filgrastim follow-on biological approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 14]. Available from:www.gabionline.net/Biosimilars/News/Filgrastim-follow-on-biological-approved-in-Brazil 
6.   GaBI Online - Generics and Biosimilars Initiative. Brazil approves first monoclonal antibody follow-on biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/Brazil-approves-first-monoclonal-antibody-follow-on-biological 
7.   GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
8.   GaBI Online - Generics and Biosimilars Initiative. Venezuelan approval for Celltrion’s Remsima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/Venezuelan-approval-for-Celltrion-s-Remsima 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.

Comments (5)

Biosimilars in LA posted 24/07/2017 - by Carlos Sanchez MD

Biologics lke Etanar, etanercept has been to succesful example of price-therapeutic value in Colombia

Response to ‘Biosimilars (?) in Latam’ posted 08/11/2013 - by Jodi H, GaBI Online Editorial Office

Dear Mr Pignataro, Thank you for your comment. Per your advice, we have updated Paraguay’s information in Table 1. Best regards, Jodi

Response to ‘Biosimilars in Latin America’ posted 07/11/2013 - by Jodi H, GaBI Online Editorial Office

Dear Mr Spitzer, Thank you for your comment. GaBI Online is a repository of generics and biosimilars information; therefore, some of the information is for archive purposes, but still worthwhile to keep in the repository for future reference and update. We welcome you to submit a paper with current data of marketed products in Latin America to GaBI Journal, please submit to editorial@gabi-journal.net. Thank you again for your interest in GaBI and your valuable feedback. Please continue to send us your comments in the future. Best regards, Jodi

Biosimilars (?) in Latam posted 27/10/2013 - by Jorge Pignataro (Paraguay/Uruguay)

As far as we know, Tidecron/Reditux has not been approved as a biosimilar , but as a " generic" using the same criteria as for small molecules , in Paraguay. The editor's comment is clear but please be so kind to clarify and double check the content before posting.

Biosimilars in Latin America posted 27/10/2013 - by Eduardo Spitzer

As a part of the Biosimilar industry in Latin America, i have to say that the article is very outdated , and it lacks o detailed information. I wish to contribute with real data of marketed produtcs. Best Regards Spitzer.eduardo@gmail.com

Generics News Research General

more

Biosimilars News Research General

more