Similar biotherapeutic products under development in Latin America

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Similar biotherapeutic products under development in Latin America

Biosimilars/General | Posted 15/11/2013 0 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].

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
bevacizumab	Breast cancer Lung cancer Ovarian cancer	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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