Biocomparables approved in Mexico

Biosimilars/General | Posted 08/04/2022 post-comment0 Post your comment

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 V22D08

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

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 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

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