Generics/General

FDA closes Zhejiang Huahai Pharmaceutical warning letter

Generics/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

Generics/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

Generics/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

Generics/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].

A European pharmaceutical strategy promoting generics and biosimilars

Generics/General | Posted 08/01/2021

The European Commission has adopted a new Pharmaceutical Strategy for Europe [1], as of 25 November 2020.

Use of generics increases during the COVID-19 pandemic in Mexico

Generics/General | Posted 21/06/2021

During the last month of July 2020, the pharmacist sector affiliated with the National Association of Medicines Retailers (Asociación Nacional de Distribuidores de Medicina A.C, ANADIM) reported an average sales growth of 23% fostered by the demand of generic medicines. 

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

Generics/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

Generics/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

Generics/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

Generics/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.