Similar biotherapeutic products approved and marketed in Latin America

Biosimilars/General | Posted 25/10/2013 9 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].

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.

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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Comments (9)

Post your comment

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'

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