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Similar biotherapeutic products approved and marketed in Latin America Posted 25/10/2013
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 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 Colombia Shanghai CP Goujian La Santé Etart etanercept
Ankylosing spondylitis Arthritis Mexico Shanghai CP Guojian Not known Fiprima filgrastim Neutropenia Brazil [5]
Eurofarma Not applicable Granulostim filgrastim Neutropenia Argentina Biosidus Not applicable Hemax epoetin alfa
Anaemia Argentina Biosidus Not applicable HHT somatropin
Pituitary dwarfism Argentina Biosidus Not applicable Hypercrit epoetin alfa
Anaemia Argentina Biosidus Not applicable Infinitam etanercept
Ankylosing spondylitis Arthritis Mexico Probiomed Not applicable Inter 2 A interferon alfa 2a Chronic hepatitis C Argentina Biosidus Not applicable Kikuzubam rituximab
Rheumatoid arthritis
Mexico Probiomed Not applicable Lenobio lenograstim
Severe chronic neutropenia Argentina Biosidus Not applicable Lumiere bevacizumab
Age-related macular degeneration (AMD) Argentina [6] Laboratorio Elea Not applicable Neutromax filgrastim Neutropenia Argentina Biosidus Not applicable Novex rituximab
Rheumatoid arthritis Argentina mAbxience Laboratorio Elea Osteofortil teriparatide Osteoporosis Argentina Biosidus Not applicable Reditux/ Tidecron rituximab
Rheumatoid arthritis Bolivia, Chile, Ecuador, Paraguay†, Peru Dr Reddy’s Laboratories
CF Recalcine (Chile) Remsima infliximab
Ankylosing spondylitis Brazil [7], Colombia [8], Venezuela [9] Celltrion/ Hospira Amarey Nova Medical Usmal rituximab
Rheumatoid arthritis Bolivia [10], Honduras [10] Biocad Not known Zedora trastuzumab
Early breast cancer Brazil [11] Biocon/Mylan Libbs Farmaceutica †approved via ‘generics’ pathway *Western Pharmaceutical and Farmindustria are subsidiaries of CF Recalcine
Editor’s comment 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 Biosimilars approved in Europe
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Non-small-cell lung carcinoma
Ovarian neoplasms
Peritoneal neoplasms
Renal cell carcinoma
Psoriasis
Psoriasis
Laboratórios
Chronic kidney failure
Prader-Willi syndrome
Turner syndrome
Chronic kidney failure
Psoriasis
Non-Hodgkin lymphoma
Leukaemia
(Withdrawn in March 2014)
Congenital agranulocytosis (Kostman’s syndrome)
Diabetic retinopathy
Non-Hodgkin lymphoma
Leukaemia
Non-Hodgkin lymphoma
Leukaemia
Western Pharmaceutical (Ecuador)*
Farmindustria (Peru)*
FAPASA (Paraguay)
Crohn’s disease
Psoriasis
Psoriatic arthritis Rheumatoid arthritis
Ulcerative colitis
Non-Hodgkin lymphoma
Leukaemia
Metastatic breast cancer
Metastatic gastric cancer
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.
Similar biotherapeutic products under development in Latin America
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
Comments (7)
Epoetin alfa - Biosidus posted 15/02/2019 - by Hugo Sotelo
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.arBlastoferon - Argentina posted 15/02/2019 - by Hugo Sotelo
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.arBiosimilars in LA posted 24/07/2017 - by Carlos Sanchez MD
Biologics lke Etanar, etanercept has been to succesful example of price-therapeutic value in ColombiaResponse 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, JodiResponse 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, JodiBiosimilars (?) 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
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