Similar biotherapeutic products under development in Latin America

Biosimilars/General | Posted 15/11/2013 post-comment0 Post your comment

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].

Latin America V13J25

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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