Pfizer to produce generic COVID-19 pill in eight countries of Latin America

Generics/News | Posted 14/01/2022 post-comment0 Post your comment

US-based pharmaceutical company Pfizer announced a licensing agreement to allow other manufacturers to produce generic versions of its COVID-19 pill Paxlovid (PF-07321332*) in order to generate more affordable access to developing countries.

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On 16 November 2021, Pfizer announced that an agreement has been signed with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, to enable 95 low- and middle-income countries to receive the pill, covering 53% of the world's population. The agreement will thus facilitate the production and distribution of the antiviral through licensing to qualified generics manufacturers, giving greater access to the global population.

In Latin America, countries that will benefit include Belize, Bolivia, El Salvador, Guatemala, Haiti, Honduras, Nicaragua and Venezuela.

The MPP will be allowed to facilitate additional production and distribution of the antiviral, pending regulatory approval, by sub-licensing to qualified generics manufacturers, in this particular case, in the eight Latin American countries. Approval is expected in the coming months.

This licence is very important because, if authorized or approved, this oral medicine is particularly suitable for low- and middle-income countries as in this case and could play a key role in saving lives, contributing to global efforts to combat the current pandemic.

In early November 2021, the drugmaker announced that the pill reduces the risk of hospitalization and death by almost 90% in people with mild to moderate COVID-19, and asked regulatory agencies in several countries to authorize its use as soon as possible.

Pfizer requested the US Food and Drug Administration (FDA) approval for the oral antiviral treatment Paxlovid to facilitate the fastest possible access to the drug [1].

On 22 December 2021, FDA issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and paediatric patients (12 years of age and older weighing at least 40 Kg) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

This will mean a step forward in the fight against this global pandemic.

Generics production would take place without Pfizer receiving patent royalty income as long as COVID-19 continues to be declared an international emergency by the World Health Organization (WHO).

*Nirmatrelvir is an antiviral medication developed by Pfizer which acts as an orally active 3C-like protease inhibitor. It is part of the nirmatrelvir/ritonavir combination sold under the brand name Paxlovid.

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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: Diferencias en estudios clínicos y farmacovigilancia de medicamentos biológicos 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.

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: Diferencias en estudios clínicos y farmacovigilancia de medicamentos biológicos 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. 

  

Reference
1. GaBI Online - MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/generics/general/mpp-agreements-allow-generics-production-of-merck-and-pfizer-s-covid-19-treatments

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