Genéricos/General

Medicines repurposing project launched in Europe

Genéricos/General | Posted 21/01/2022

In late October 2021, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced the launch of a pilot project to support the repurposing of medicines.

MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments

Genéricos/General | Posted 10/12/2021

In October and November 2021, Merck and Pfizer signed licensing agreements with the United Nation’s backed Medicines Patent Pool (MPP) to help increase access to their investigational COVID-19 oral antiviral treatment options. Respectively, these are molnupiravir and Paxlovid. Creating these royalty free licences will allow for generic versions of the drugs to be produced and distributed in approximately 100 low- and middle-income countries worldwide.

FDA closes Zhejiang Huahai Pharmaceutical warning letter

Genéricos/General | Posted 19/11/2021

The US Food and Drug Administration (FDA) has stated that it has closed the warning letter issued to Chinese manufacturer Zhejiang Huahai Pharmaceutical in 2018.

FDA reaches 100 generic approvals

Genéricos/General | Posted 12/11/2021

As of September 2021, the US Food and Drug Administration (FDA) has reached an important milestone of approving more than 100 generic drug applications with a competitive generic therapy (CGT) designation.

New five-year medicines agreements in Australia

Genéricos/General | Posted 24/09/2021

The Australian Government has entered into five-year strategic agreements with Medicines Australia and the Generics and Biosimilar Medicines Association (GBMA), to improve access to affordable, innovative, and life-saving therapies, vaccines and medicines.

Generics applications under review by EMA – July 2021

Genéricos/General | Posted 23/07/2021

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

Una estrategia farmaceútica europea para promover genéricos y biosimilares

Genéricos/General | Posted 08/01/2021

Desde el 25 de noviembre de 2020, la Comisión Europea ha adoptado una nueva estrategia farmaceútica para Europa [1].

El uso de genéricos aumenta durante la pandemia de COVID-19 en México

Genéricos/General | Posted 21/06/2021

Durante el pasado mes de julio del 2020, el sector de farmacias afiliadas a la Asociación Nacional de Distribuidores de Medicinas (ANADIM), reportó un crecimiento en ventas promedio de 23% impulsado por la demanda de medicamentos genéricos.

COVID-19 IP waivers could lead to global pharma patent changes

Genéricos/General | Posted 11/06/2021

At the Nikkei Future of Asia conference in Tokyo on 20 May 2021, Malaysian Prime Minister Tan Sri Muhyiddin Yassin announced that he believes Asia should lead in opening-up patent protections to produce generic versions of life-saving medicines. 

COVID-19 favipiravir treatment production opens up in Thailand

Genéricos/General | Posted 04/06/2021

In Thailand, the patent application for favipiravir, a drug widely used to treat COVID-19, has been rejected. This now allows local generics production of the antiviral medication and human trials of a Thai-made version of the drug are underway.