First approvals of similar biotherapeutics in seven Latin American countries

Home/Reports | Posted 16/01/2024 post-comment0 Post your comment

In their review, Machado and colleagues 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].

Latin America V13J25

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.

GW 5066G 2 0173G Fig1

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].

Related articles
Study of the use of generic and biosimilar drugs in Latin America

Recommendations to address challenges to biosimilars in Latin America 

Similar biotherapeutic products approved and marketed in Latin America

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Consulta pública para la modificación de la regulación de biosimilares

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Consulta pública para la modificación de la regulación de biosimilares

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

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 et al. Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(4):184-92. doi:10.5639/gabij.2021.1004.023

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.

 

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010