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.

Generics in India

Genéricos/General | Posted 30/04/2021

India is the world’s largest generic drugs producer, yet the generics market within the country is relatively small. In a recent article [1], Sajid Sheikh and Gunjan Deshpande of the Maharashtra National Law University, Mumbai, explore the current status of generics in India.

US$1.2 FDA contract for generic drug computational tool

Genéricos/General | Posted 16/04/2021

The US Food and Drug Administration (FDA) Office of Generic Drugs (ODG) has awarded a US$1.2 million contract to support the development of a computational tool that will aid generic drug research.

Opportunities for generics with Korean patent expires in 2021

Genéricos/General | Posted 05/03/2021

As part of ongoing action to improve the quality of generics and ensure an efficient and competitive generics market, the Korean Ministry of Food and Drug Safety (MFDS) announced that 158 patents for pharmaceutical products will expire in 2021.

AIFA updates the Transparency Lists for generics

Genéricos/General | Posted 26/02/2021

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 15 January 2021 the update of its Transparency Lists (liste di trasparenza).