Biocomparables approved in Mexico

In Mexico, biological products with expired patents are known as biocomparable biotechnology drugs (medicamentos biotecnológicos biocomparables). The regulatory body in charge of approving biocomparables is the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS).

COFEPRIS is a department within the Mexican Secretariat of Health or the Ministry of Health (Secretaría de Salud, SSA) with technical, administrative and operational autonomy, it was founded in 2001 to be in charge of the control of health facilities, and monitoring the manufacturing, import, or export and advertising activities of health products, and health regulation of the country, which was previously exercised by the former Undersecretariat of Regulation and Sanitary Promotion of the SSA.

The SSA is a member of the Executive Cabinet and is the government department in charge of all social health services in Mexico. SSA is as an integral part of the Mexican health system, primarily responsible for disease prevention and promotion of the population's health and establishes State policies so that the population may exercise its right to health protection.

The legal framework for registration of biocomparables was established in Mexico in 2009 through COFEPRIS. The article 222 Bis published in the Official Journal of the Federation (DOF) on 11 June 2009, establishes the legal regime for the registration of biocomparable biotechnological drugs [1, 2].

On 9 June 2019, COFEPRIS published the latest version of the list of approved biocomparable drugs, see Table 1.

There are currently 13 biocomparables approved in Mexico, see Table 1 in the following therapeutic classes: 1) erythropoiesis-stimulating agent, 2) granulocyte colony-stimulating factor, 3) endogenous growth hormone, 4) follicle-stimulating hormone (FSH), 5) insulin, 6) tumour necrosis factor (TNF) inhibitor, and 7) antivirals and interferon.

Table 1: Biocomparables approved by COFEPRIS

Product name	Active substance	Therapeutic area	Manufacturer/Company name
Abasaglar 3	Insuline glargine	Diabetes mellitus type 1 and type 2	Eli Lilly
Arabinev	Interferon beta 1b	Multiple sclerosis (clinically isolated syndrome) Relapsing remitting sclerosis Secondary progressive multiple sclerosis with active disease, evidenced by relapses or marked neurological deterioration in the last two years	Pisa
Bioyetin	Erythropoietin alfa	Erythropoiesis-stimulating antianemics	Probiomed
Corneumon	Follitropin alfa	Ovarian function stimulant	Corne
Galactus	Insuline glargine	Diabetes Mellitus type 1 and type 2	Pisa
Filatil	Filgrastim	Myeloid leukemia Neutropenia	Probiomed
Omnitrope	Somatropin	Disorder due to inadequate endogenous growth hormone secretion Growth failure associated with chronic renal failure Growth failure associated with Turner's syndrome	Sandoz
Remsima	Infliximab	Adult and pediatric Crohn's disease Ankylosing spondylitis Fistulizing Crohn's disease Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Psoriasis	Celltrion
Rigetuxer	Rituximab	Granulomatosis with wegener's polyangiitis Microscopic polyangiitis Low grade non-Hodgkin's lymphoma	Pisa
Urifron	Interferon alfa 2b	Antiviral	Probiomed
Uribeta	Interferon beta 1b	Relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis with active disease, evidenced by relapses or marked neurological deterioration within the past two years	Probiomed
Valvey	Insuline glargine	Diabetes mellitus type 1 and type 2	Wockhardt Ltd
Zarzio	Filgrastim	Neutropenia	Sandoz

Data collected on 8 April 2022.
Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)

Editor’s comment
European Medicines Agency 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 but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘biocomparables’ approved in Mexico might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related articles
Mexican guidelines for biocomparables

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: Biocomparables aprobados en México 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. LATIN AMERICAN FORUM 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: Biocomparables aprobados en México !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. GaBI Online - Generics and Biosimilars Initiative. Mexican guidelines for biocomparables [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 8]. Available from: www.gabionline.net/Guidelines/Mexican-guidelines-for-biocomparables
2. GaBI Online - Generics and Biosimilars Initiative. Regulation of biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 8]. Available from: www.gabionline.net/Biosimilars/Research/Regulation-of-similar-biotherapeutic-products-in-Latin-America

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Source: COFEPRIS