Generics

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

Generics/News | Posted 14/01/2022

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

Generics/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.

First eslicarbazepine epilepsy generic to be approved in China

Generics/News | Posted 10/12/2021

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

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.

Pfizer and Merck COVID-19 antiviral progress

Generics/News | Posted 12/11/2021

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

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.

Call for drug pricing transparency

Generics/Research | Posted 05/11/2021

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

Generics/News | Posted 05/11/2021

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.

High price of cancer medicines make treatment unaffordable globally

Generics/Research | Posted 29/10/2021

Cancer is the leading cause of death worldwide. Currently, there are increasing concerns about the price of cancer medicines and how this can limit patient access to lifesaving treatments. Now, a new study published in Applied Health Economics and Health Policy [1] calls for strengthened pricing policies that can ensure affordable cancer treatment for all.

Oncology generics launched by MSN Labs and Natco Pharma

Generics/News | Posted 29/10/2021

In late September 2021, MSN Labs launched Cabolong, a branded generic of Cabozantinib for treatment of renal cell carcinoma in India. This was followed by the early October announcement that in the US, Natco Pharma launched 10 mg strength everolimus tablets, an oncology generic of Novartis’ Afinitor.

US brand-name drug market exclusivity periods remain relatively unchanged over the past decade

Generics/Research | Posted 22/10/2021

The passage in 1984 of the Hatch-Waxman Act set into motion sweeping changes to the US brand-name and generic drug competitive environment. It greatly increased generic drug competition for small-molecule drugs, by establishing a new abbreviated new drug application (ANDA) generic drug approval process that substantially reduced the time and cost associated with a generic drug marketing application submitted to the US Food and Drug Administration (FDA). In addition, it created incentives for challenges to brand-name drug patents, while also creating incentives for continued medical innovation and new drug development by drug innovators.

Considerations for the evaluation of generic IUDs containing levonorgestrel

Generics/Research | Posted 15/10/2021

Fertility regulation benefits the population, protecting the right to life and health, supporting the right of individuals to enjoy their sexuality and the right of children to be born wanted. In addition, it safeguards people’s freedom of conscience to decide whether or not to use a contraceptive method, based on their personal values, safeguards the principle of non-maleficence and the principle of equity and justice. This is fulfilled when services are universally accessible without discrimination and authorities monitor that this condition is respected. Currently, different types of contraceptive methods are available, which are classified into hormonal, barrier, long-acting reversible contraception, emergency contraception and sterilization. All of them must meet the basic conditions of efficacy, safety, acceptability, availability and reversibility.

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.

Generic pharmaceutical policies in the MENA region

Generics/Research | Posted 17/09/2021

Healthcare systems in the Middle East & North Africa (MENA) region face challenges in service funding and delivery with policy emphasis in the region currently focused on controlling pharmaceutical expenditure. A key component of pharmaceutical cost-containment is a strong policy for generics aiming to improve uptake and access.

Sandoz launches ferumoxytol and pemetrexed generics

Generics/News | Posted 03/09/2021

Sandoz has launched ferumoxytol iron deficiency anaemia (IDA) treatment in the US and pemetrexed oncology treatment in Europe.

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].

The generics market in Brazil

Generics/Research | Posted 16/07/2021

The Brazilian pharmaceutical market has undergone many changes since the introduction of generic drug laws.

US generic approvals for Acrux and Cipla

Generics/News | Posted 16/07/2021

In late June 2021, Australian pharmaceutical company Acrux received United State Food and Drug Administration (FDA) approval to market its generic version of Vallant’s Jubila (efinaconazole). In addition, Indian generics maker Cipla received final FDA approval for a generic version of Sunovion Pharmaceuticals Inc’s Brovana, an arformoterol tartrate inhalation solution.

Laws on packaging, substitution and prescription of generics in Brazil

Generics/Research | Posted 09/07/2021

According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.

Legal requirements on equivalence studies for generics in Brazil

Generics/Research | Posted 02/07/2021

The creation of the legal system for generic medicines began with the introduction of Law Number 9787 in February 1999 (Brazil 1999). According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.