Access to biosimilars for cancer treatments in Latin America

Biosimilars/Research | Posted 26/08/2022 post-comment0 Post your comment

In many Latin America countries, patient access to biosimilars for cancer treatment remains restricted. In particular for patients with breast cancer and colorectal cancer, biosimilars can be a step further to increasing access to care [1].

Cancer Cell V13I20

The governments of several countries in Latin America have developed, or are still developing, abbreviated regulatory pathways but also achieved a solid developmental and manufacturing base to increase the access to biosimilars. However, not all Latin American countries have the same biosimilar accessibility, due to many factors which include different legislature, regulatory initiatives began later or less market opportunities.

The countries with most approved biosimilars in Latin America are Argentina, Brazil and Mexico with 44 products approved, followed by Bolivia, Colombia, Ecuador and Peru (Andean region) with 14 biosimilars approved, and Chile, Paraguay, Uruguay and Venezuela (MERCOSUR trade bloc) with 18 biosimilars approved as of 2020 [1].

Those countries with different and inconsistent regulatory processes for biosimilars like Chile, Colombia, Ecuador, Guatemala and Peru have the intrinsic need to increase access to biological treatments for patients with cancer. In Latin America, breast cancer and colorectal cancer are responsible for the second and third highest cancer-related mortality.

Biosimilars have been broadly recognized as one of the many strategies to improve the affordability of cancer care globally but their acceptance in these five countries of Latin America has been slow. Table 1 presents the biosimilars approved for the treatment of breast cancer and colorectal cancer in Chile, Colombia, Ecuador, Guatemala and Peru [1].

Table 1: Approvals for breast cancer and colorectal cancer biosimilars by year and in five Latin American countries
Biosimilars Countries
Chile Colombia Ecuador Guatemala Peru
Trastuzumab-anns*(ABP 890) -- -- 2021 -- 2020
Trastuzumab-pkrb* (CT-P6) 2020 2021 2020 -- 150 mg dose approved in 2020
420 mg dose approved in 2021
Trastuzumab-dkst* (MYL-1401O) 2019 2018 -- 2017 2019
Trastuzumab-qyyp* (PF-05280014) -- 2019 2021 -- 2019
Bevacizumab-awwb† -- 2019 2021 -- 2021
MB02† Under review 2020 -- -- --
Source ISP INVIMA ARCSA DRCPFA DIGEMID
*Biosimilar to the originator trastuzumab.
†Biosimilar to the originator bevacizumab.
ARCSA: Agencia Nacional de Regulación, Control y Vigilancia Sanitaria; DIGEMID: Dirección General de Medicamentos, Insumos y Drogas; DRCPFA: Departamento de Regulación y Control de Productos Farmacéuticos y Afines; ISP: Instituto de Salud Pública; INVIMA: Instituto Nacional de Vigilancia de Medicamentos y Alimentos.

 

Trastuzumab was the first biosimilar approved for breast cancer treatment (trastuzumab-pkrb [CT-P6]) in 2017 in Europe and the US [2, 3]. Since then, EMA and FDA have approved several trastuzumab biosimilars for breast cancer treatment, and three trastuzumab biosimilars were launched in 2020 in the US [4]. In 2021, there was a total of four different trastuzumab biosimilars approved in Latin America, with seven different brand names marketed in Argentina, Brazil, Colombia and Peru [5].

GaBI Journal Citation Impact
2.2 – CiteScore 2021 (calculated on 5 May 2022)
2.2 – CiteScoreTracker 2022 (Last updated on 5 August 2022)

Submit a manuscript to GaBI Journal

Related articles
Regulatory landscape for biosimilars in Latin America

EMA recommends approval of bevacizumab biosimilar Vegzelma

Overview of monoclonal antibody biosimilars in Latin America

Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal

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 this week’s headline article: Acceso a biosimilares para tratamientos contra el cáncer en América Latina

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.

Vea el artículo principal de esta semana: Acceso a biosimilares para tratamientos contra el cáncer en América Latina

!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. Teran E, Gomez H, Hannois D, et al. Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective. Lancet Oncol. 2022;23(7):e348-e358.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar approvals and launches in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from: www.gabionline.net/biosimilars/general/Biosimilar-approvals-and-launches-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Current status of monoclonal antibody biosimilars approved in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Aug 26]. Available from:
www.gabionline.net/biosimilars/general/current-status-of-monoclonal-antibody-biosimilars-approved-in-latin-america

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 © 2022 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Successful trials for Sandoz and Lannett biosimilars
Clinical Trials 2 V13K29
Biosimilars/Research Posted 30/09/2022
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