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Similar biotherapeutic products under development in Latin America Posted 15/11/2013

Last update: 15 November 2013

Similar biotherapeutic products are high on the health policy agenda in Latin America, due to the fact that they are less costly and therefore have the potential to increase access to life-saving drugs. Within individual Latin American countries, the regulatory processes and stages of implementation of similar biotherapeutic products regulation vary widely. Despite this, Latin America is moving towards increasing standards of regulation for these products [1, 2].

This fact, coupled with the imminent expiration of a number of patents on biological products, has led to increased interest in producing similar biotherapeutic products for the region. Similar biotherapeutic products for rituximab and etanercept have already been approved for marketing in Latin America [3], and many others are in the pipeline, see Table 1.

Similar biotherapeutic products under development in Latin America

Active substance

Therapeutic area

Product name

Stage of development

Company

Latin American partner

bevacizumab

Breast cancer
Lung cancer
Ovarian cancer

BCD-021

Clinical:
phase III NSCLC

Biocad

Biocad Brazil

Unknown

R & D

Grupo Insud (Argentina)

Not applicable

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis

Remsima

Filed

Celltrion

OliMed

etanercept

Ankylosing spondylitis
Arthritis
Psoriasis

Reumatocept

Clinical:
phase III RA

Shanghai CP Goujian

EMS

Unknown

R & D

Grupo Insud (Argentina)

Not applicable

Unknown

R & D

Amega Biotech (Argentina)

Not applicable

Unknown

R & D

Biosidus (Argentina)

Not applicable

rituximab

Rheumatoid arthritis
Non-Hodgkin lymphoma
Leukaemia

GP2013

Clinical:
phase I/II RA
phase III FL

Sandoz

-

CT-P10

Clinical:
phase I RA
phase III FL

Celltrion

OliMed

BI 695500

Clinical: 
phase III RA
phase III FL

Boehringer Ingelheim

-

PF-05280586

Clinical:
phase I/II RA

Pfizer

-

MK-8808

Clinical:
phase I RA

Merck Sharp & Dohme

-

MabionCD20

Clinical

Mabion

Human Bioscience*

Unknown

Clinical:
phase III DLBCL

Grupo Insud (Argentina)

Not applicable

BCD-020

Clinical:
phase III RA

Biocad

Biocad Brazil

Unknown

R & D

Biosidus (Argentina)

Not applicable

trastuzumab

Breast cancer
Stomach cancer

CT-PO6

Clinical:
phase III BC

Celltrion

OliMed

BCD-022

Clinical:
phase III BC

Biocad

Biocad Brazil

Unknown

R & D

Grupo Insud (Argentina)

Not applicable

BC: Breast cancer; DLBCL: Diffuse large B-cell lymphoma; FL: Follicular Lymphoma; NSCLC: Non-Small Cell Lung Cancer; RA: Rheumatoid Arthritis.
* Partnership with Human Bioscience established in July 2012 for commercialization in Colombia, Ecuador, Peru and Venezuela.
Source: PM live 

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. EMA 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 article

Biosimilars approved in Europe

References

1.  Mysler E, Scheinberg M. Biosimilars in rheumatology: a view from Latin America. Clin Rheumatol. 2012;31(9):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 2013 Oct 15]. Available from: www.gabionline.net/Biosimilars/Research/Regulation-of-similar-biotherapeutic-products-in-Latin-America 

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