Access to biosimilars for cancer treatments in Latin America

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].

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
Biosimilars	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].

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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

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