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

Last update: 1 February 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

Chronic hepatitis C

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

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

Celltrion/ Hospira

Amarey Nova Medical 

Usmal

rituximab

Rheumatoid arthritis
Non-Hodgkin lymphoma
Leukaemia

Bolivia [9],
Honduras [9]

Biocad

Not known

Zedora

trastuzumab

Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer

Brazil [10]

Biocon/Mylan

Libbs Farmaceutica

Zyrop

epoetin alfa

Anaemia
Cancer
Chronic kidney failure

Argentina

Biosidus

Not applicable

†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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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.ar

Blastoferon - 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.ar

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