Similar biotherapeutic products approved and marketed in Latin America

Biosimilars/General | Posted 25/10/2013 post-comment9 Post your comment

Last update: 29 November 2019

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

Latin America V13J25

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, including productos bioterapéuticos similares (similar biotherapeutic products), in Colombia [4].

To date, similar biotherapeutic products for bevacizumab, epoetin alfa, etanercept, filgrastim, infliximab, interferon alfa and rituximab 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 approved/ marketed Company Latin American partner
Bevax bevacizumab Breast neoplasms Fallopian tube neoplasms
Non-small-cell lung carcinoma
Ovarian neoplasms
Peritoneal neoplasms
Renal cell carcinoma
Argentina mAbxience Not known
Blastoferon interferon alfa 1a Multiple sclerosis Argentina Biosidus Not applicable
Bioferon interferon alfa 2b Chronic hepatitis C Argentina Biosidus Not applicable
Escleroferon interferon beta 1a Multiple sclerosis Argentina Biosidus Not applicable
Etanar etanercept Ankylosing spondylitis Arthritis
Psoriasis
Colombia Shanghai CP Goujian La Santé
Etart etanercept Ankylosing spondylitis Arthritis
Psoriasis
Mexico Shanghai CP Guojian Not known
Fiprima filgrastim Neutropenia Brazil [5] Eurofarma 
Laboratórios 
Not applicable
Granulostim filgrastim Neutropenia Argentina Biosidus Not applicable
Hemax epoetin alfa Anaemia
Chronic kidney failure
Argentina Biosidus Not applicable
HHT somatropin Pituitary dwarfism
Prader-Willi syndrome
Turner syndrome
Argentina Biosidus Not applicable
Hypercrit epoetin alfa Anaemia
Chronic kidney failure
Argentina Biosidus Not applicable
Infinitam etanercept Ankylosing spondylitis Arthritis
Psoriasis
Mexico Probiomed Not applicable
Inter 2 A interferon alfa 2a Chronic hepatitis C Argentina Biosidus Not applicable
Kikuzubam rituximab Rheumatoid arthritis
Non-Hodgkin lymphoma
Leukaemia
Mexico
(Withdrawn in March 2014) 
Probiomed Not applicable
Lenobio lenograstim Severe chronic neutropenia
Congenital agranulocytosis (Kostman’s syndrome)
Argentina Biosidus Not applicable
Lumiere bevacizumab Age-related macular degeneration (AMD)
Diabetic retinopathy
Argentina [6] Laboratorio Elea Not applicable
Neutromax filgrastim Neutropenia Argentina Biosidus Not applicable
Novex rituximab Rheumatoid arthritis
Non-Hodgkin lymphoma
Leukaemia
Argentina mAbxience Laboratorio Elea
Osteofortil teriparatide Osteoporosis Argentina Biosidus Not applicable
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 [7], Colombia [8], Venezuela [9] Celltrion/ Hospira Amarey Nova Medical 
Usmal rituximab Rheumatoid arthritis
Non-Hodgkin lymphoma
Leukaemia
Bolivia [10], Honduras [10] Biocad Not known
Zedora trastuzumab Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer
Brazil [11] Biocon/Mylan Libbs Farmaceutica

†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.

Reditux was first approved in India as a stand-alone biological product (not as a biosimilar) in 2007 when the Indian biosimilars regulatory guidelines had not yet been established.

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. Trastuzumab and Bevacizumab products approved in Australia and Argentina [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-and-Bevacizumab-products-approved-in-Australia-and-Argentina
7. 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 
8. 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
9. 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 
10. GaBI Online - Generics and Biosimilars Initiative. Rituximab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/News/Biocad-registers-rituximab-similar-biotherapeutic-product-in-Bolivia-and-Honduras
11. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilars receive EMA and ANVISA approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 15]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilars-receive-EMA-and-ANVISA-approval

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comment icon Comments (9)
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Posted 02/03/2021 by Miriam N, GaBI Online Editorial Office
Response to 'Epoetin alfa - Biosidus'

Dear Hugo Sotelo,
Thank you for your valuable comments and insight received on 15 February 2019, we have followed-up on your suggestion and researched the issue further. As a result, we have updated article ‘Similar biotherapeutic products approved and marketed in Latin America’ with the current information.
We very much appreciate your kind feedback, and please continue with your valuable comments to GaBI Online.
Thank you for your interest in GaBI. Please enjoy the quality information and content published under GaBI (GaBI Online and GaBI Journal).
Best Regards, Miriam

Posted 02/03/2021 by Miriam N, GaBI Online Editorial Office
Response to 'Blastoferon - Argentina'

Dear Hugo Sotelo,
Thank you for your valuable comments and insight received on 15 February 2019, we have followed-up on your suggestion and researched the issue further. As a result, we have updated article ‘Similar biotherapeutic products approved and marketed in Latin America’ with the current information.
We very much appreciate your kind feedback, and please continue with your valuable comments to GaBI Online.
Thank you for your interest in GaBI. Please enjoy the quality information and content published under GaBI (GaBI Online and GaBI Journal).
Best Regards, Miriam

Posted 15/02/2019 by Hugo Sotelo
Epoetin alfa - Biosidus

Dear, I also ask you to correct an error referred to the product "epoetin alfa" of Biosidus that is marketed through two brands in Argentina: Hemax and Hypercrit.
It is not marketed with the brand mentioned in the article (Zyrop).
Thank you
h.sotelo@biosidus.com.ar

Posted 15/02/2019 by Hugo Sotelo
Blastoferon - Argentina

Dear, I am asking you to correct an error related to the Blastoferon product since it is interferon beta 1a and the indication is "multiple sclerosis" and not "Chronic hepatitis C".
Thank you
h.sotelo@biosidus.com.ar

Posted 24/07/2017 by Carlos Sanchez MD
Biosimilars in LA

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

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

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

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

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

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

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.

Posted 27/10/2013 by Eduardo Spitzer
Biosimilars in Latin America

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

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