First approvals of similar biotherapeutics in seven Latin American countries

In their review, Machado et al. examine the transparency and regulatory guidelines pertaining to the licensing of biosimilars, as well as the count of biosimilars granted approval by 13 medicines regulatory authorities [1].

This article discusses the first biosimilar to receive approval following the issuance of licensing guidelines by regulatory authorities around the world.

In 2006, the European Medicines Agency became the pioneer regulatory authority to authorize a biosimilar – Sandoz's human growth hormone somatropin, a reference to Omnitrope. Health Canada and Federal Commission for the Protection against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) followed suit in 2009 and 2010, respectively, endorsing the same product, albeit referred to as biocomparable in Mexico at the time. Subsequent approvals for the first biosimilars by Australia's Therapeutic Goods Administration (TGA) and the US Food and Drug Administraion (FDA) occurred in 2010 and 2015, as depicted in Figure 1.

ANMAT: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; ANVISA: Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária); COFEPRIS: Federal Commission for the Protection against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios); DIGEMID: Dirección General de Medicamentos, Insumos y Drogas; DRCPFA: Departamento de Regulación y Control de Productos Farmacéuticos y Afines; EMA: European Medicines Agency; FDA: US Food and Drug Administration; INVIMA: Instituto Nacional de Vigilancia de Medicamentos y Alimentos; ISP: Instituto de Salud Pública de Chile; TGA: Therapeutic Goods Administration.

Table 1 presents data of the first follow-on biologicals approved in seven Latin American countries

Table 1: First follow-on biological approved following the release of licensing guidelines in Latin America
Year	Regulatory authority (country)	Nonproprietary name (brand name)	Manufacturer
2010	COFEPRIS (Mexico)	Somatropin (Omnitrope)	Sandoz
2012	DRCPFA (Guatemala)	Filgrastim (Zarzio)	Sandoz
2013	ANMAT (Argentina)	Rituximab (Novex)	Elea Phoenix
2015	ANVISA (Brazil)	Filgrastim (Fiprima) Infliximab (Remsina)	Eurofarma Laboratório Celltrion
2017	ISP (Chile)	Infliximab (Remsina) Insulin gargline (Basaglar)	Laboratorios Saval Eli Lilly
2017	DIGEMID (Peru)	Infliximab (Flixceli)	Celltrion
2018	INVIMA (Colombia)	Trastuzumab (Ogivri) Trastuzumab (Trazimera)	Mylan GmbH Pfizer

ANMAT: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; ANVISA: Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária); COFEPRIS: Federal Commission for the Protection against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios); DIGEMID: Dirección General de Medicamentos, Insumos y Drogas; DRCPFA: Departamento de Regulación y Control de Productos Farmacéuticos y Afines; INVIMA: Instituto Nacional de Vigilancia de Medicamentos y Alimentos.

Since then, additional follow-on biologicals have been approved by the respective regulatory authorities in Latin America, notably Brazil’s ANVISA despite Mexico’s COFEPRIS is the first regulatory authority to have approved a biocomparable.

By mid-May of 2023, ANVISA had approved 52 follow-on biological/biosimilar products within the classes of: 1) human growth hormone; 2) granulocyte colony-stimulating factor; 3) insulin; 4) tumour necrosis factor (TNF)-inhibitor; and 5) monoclonal antibody for use in Brazil [2].

Investment in biosimilars in Latin American countries is increasing year on year and regulatory authorities in many Latin American countries have been redesigned and standardized for the approval of biosimilars. However, local regulations vary between countries [3].

Recommendations to address challenges to biosimilars in Latin America

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References
1. Machado FLDS, Cañás M, Doubova SV, Urtasun MA, Marín GH, Osorio-de-Castro CGS, et al. Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison. Regul Toxicol Pharmacol. 2023 Sep 1;144:105485. doi: 10.1016/j.yrtph.2023.105485. 2.
2. Cestari de Oliveira SH. Follow-on biologicals/biosimilars approved in Brazil: May 2023 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(2):67-72. doi:10.5639/gabij.2023.1202.012
3. Ortiz-Prado E, Ponce-Zea J, Vasconez JE, et al. Current trends for biosimilars in the Latin American market. Generics Biosimilars Initiative Journal. (GaBI Journal). 2020;9(2):64-74. doi:10.5639/gabij.2020.0902.011

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