Generics
Generics applications under review by EMA – January 2022
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].
Medicines repurposing project launched in Europe
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.
Pfizer to produce generic COVID-19 pill in eight countries of Latin America
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.
MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments
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.
First eslicarbazepine epilepsy generic to be approved in China
In China, the Yangtze River Pharmaceutical Group submitted the first marketing application of a class 3 generic drug, eslicarbazepine acetate, for use to treat patients with epilepsy, on 15 October 2021.
FDA closes Zhejiang Huahai Pharmaceutical warning letter
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.
Pfizer and Merck COVID-19 antiviral progress
Pfizer has announced that its COVID-19 oral antiviral candidate, Paxlovid, can significantly reduce hospitalization and death of COVID patients. At the same time, Merck is under pressure to get its COVID-19 antiviral, molnupiravir, to reach those in developing countries.
FDA reaches 100 generics approvals
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.
Call for drug pricing transparency
By 2023, pharmaceutical expenditure is expected to reach US$1.5 trillion [1]. This causes significant strain on healthcare systems worldwide and work is underway to bring pharmaceuticals’ spending down.
Sun Pharma and Dr Reddy’s generics progress in EU and US
October 2021 saw the steps forward in the approval of a Sun Pharmaceutical’s sitagliptin fumarate generic in Europe, and Dr Reddy’s lenalidomide generic in the US.
