Regulation of similar biotherapeutic products (SBPs) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region is moving towards increasing standards of regulation for these products [1, 2].
Some intended copies of originator biologicals have already been licensed in Latin America without biosimilars regulations being in place and therefore without adequate clinical testing being performed. In Colombia, an etanercept SBP (Etanar) has been licensed; while in Bolivia, Chile, Peru (Reditux) and Mexico (Kikuzubam) – a rituximab SBP has been licensed, all prior to appropriate regulations being approved.
The rising growth of the middle class in the region has brought about a substantial increase in healthcare spending leading inevitably to increased use of less costly biosimilars. For example, in Brazil, biologicals account for less than 3% of prescriptions but more than 40% of the government’s drug budget.
Other countries in Latin America already have or are in the process of creating regulations covering SBPs, see Table 1.
Table 1: Similar biotherapeutic products regulations in Latin America
|| Name for biosimilars
|| Regulatory authority
|| Relevant law
|| Year of publication
|| Issues left to discretion of regulatory authority
|| Medicamento biológico similar (similar biological medicines)
|| Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
|| Legislation numbers 7075 and 7729
|| Not stated
|| Ministerio de Salud y Deportes
|| No regulation
|| Follow-on biological products
|| Agência Nacional de Vigilância Sanitária (ANVISA)
|| Resolution no. 55/2010
- Type of studies
- Other requisites
|| Biosimilares (biosimilar)
|| Agencia Nacional de Medicamentos (ANAMED)
|| Regulations of the National System for the Control of Pharmaceutical Products for Human Use D.S. 3/2010
|| Draft guidance 2011
- Type of studies
- Extrapolation to other indications
Medication of successor biological origin
| Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
|| Ministerial Decree 677/1995
|| Draft guidance 2013
| Biosimilar medication
|| Ministerio de Salud
|| Decree no. 37006
|| - Whether to use another guideline in some circumstances
|| Known biological product
|| Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)
|| Resolution no. 56/2011
|| Ministerio de Salud Pública y Asistencia Social
|| Technical standard 67-2010
| Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
|| Article 222 bis in the Mexican Health Law (Articule 39 de la Ley Orgánica de la Administración Pública Federal y 222 Bis de la Ley General de Salud)
- Need for clinical studies
- Type of studies
| Not stated
|| Ministerio de Salud Panama (MINSA)
|| Executive Decree no. 340
|| Producto biológico similar (similar biological product)
|| Ministerio de Salud Peru (MINSA)
|| Supreme Decree no. 016-2011-SA
The trend in Latin America is to adopt guidelines for similar biotherapeutic products based on accepted international standards, such as those of the World Health Organization. This is the case in Argentina, Brazil, Chile, Costa Rica, Guatemala, Panama and Peru where recent guidelines have been developed based on and/or taking into consideration internationally accepted standards .
Although many of the guidelines are based on regulations and guidelines from around the world, including the World Health Organization’s ‘Similar Biological Product Guidelines’, one criticism is that they are too vague, for example, the type of studies required, extrapolation to other indications or even which guidelines to be used are left to the regulatory authority. This could lead to different standards for different products and reduce confidence in the use of SBPs approved in the region.
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.
Peruvian guidelines for productos biológicos similares
Argentinian guidelines for similar biological medicines
Colombia issues draft decree for registration of biosimilars
Brazilian guidelines for follow-on biological products
Mexican guidelines for biocomparables
Proposed biosimilars guidelines for Chile
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.
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