Generics

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.

Backlog of drug patents in Brazil

Generics/Research | Posted 25/06/2021

In an article on ‘How much does the backlog on drug patents cost for health in Brazil?’, Jannuzzi et al. in 2017 [1] showed backlogs in the analysis of patent applications in Brazil. These delays, known as ‘backlogs‘, extend the term of patents granted on medicines and delay the entry of generics into the market.

Natco cancer generic approval and advances for Lannett asthma and diabetes products

Generics/News | Posted 25/06/2021

In early June 2021, US Food and Drug Administration (FDA) approved Natco Pharma’s abbreviated new drug application (ANDA) for carfilzomib vials, a generic version of anticancer drug Kyprolis. It also accepted Lannett’s ANDA for their generic version of asthma treatment Adavir Diskus, fluticasone propionate and salmeterol inhalation powder.

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.

FDA approval for schizophrenia and HIV generics from Zydus Cadila and Lupin

Generics/News | Posted 21/06/2021

On 27 May 2021, Zydus Cadila received US Food and Drug Administration (FDA) approval to market fluphenazine hydrochloride tablets which is used to treat schizophrenia and other types of mental condition. On 7 June 2021, Lupin Ltd received approval for emtricitabine and tenofovir disoproxil fumarate tablets which are used in combination with other antiretroviral agents for the treatment of HIV.

Non-profit generics manufacturers in the US reduce foreign dependence

Generics/Research | Posted 11/06/2021

Non-profit generics drug manufacturers have the potential to make important contributions to reduce foreign dependence on generic drugs in the US, argues an article published in The Journal of Law Medicine and Ethics [1].

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.

More out-of-pocket costs for US patients with rising prescription drug prices

Generics/Research | Posted 31/05/2021

Increasing prices of brand-name drugs in the US, leaves patients with increasing costs at the pharmacy, says a study published in JAMA Network Open [1].

Zydus Cadila and Sandoz generics approvals in North America

Generics/News | Posted 31/05/2021

In April 2021, Zydus Cadila received final approval from the US Food and Drug Administration to market its ibrutinib and macitentan generics. In addition, in May 2021, Sandoz Canada announced the launch of their pirfenidone, a generic version of F. Hoffmann-La Roche’s Esbriet®.

Difficult-to-make drugs meet US quality standards

Generics/Research | Posted 14/05/2021

Difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the country, finds a study published in JAMA Network Open [1].

New in vitro–in vivo simulations predict generic bioequivalence

Generics/Research | Posted 07/05/2021

If we can predict the outcome of bioequivalence studies in the generic drug development process, we can save time and money. Now, a new in vitro–in vivo simulation (IVIVS) approach to predict the in vivo outcome of these studies, published in Materials [1], has been developed by researchers National and Kapodistrian University of Athens.

EMA recommends approval of abiraterone and ioflupane (123I) generics

Generics/News | Posted 07/05/2021

The European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) recommended granting marketing authorizations for two generic medicinal products at its April 2021 meeting.

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.

Tentative US approval for Symbicort generic

Generics/News | Posted 23/04/2021

On 8 March 2021, Viatris Inc and Kindeva Drug Delivery LP announced that the US Food and Drug Administration (FDA) has granted the tentative approval of their generic version of Symbicort® (budesonide/formoterol).

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.

Dispensing branded drugs costs Medicare over a billion dollars

Generics/Research | Posted 09/04/2021

Branded drugs dispensed instead of generics at the request of physicians and patients have incurred annual costs of over US$1 billion to the Medicare programme. and US$270 million to patients, reveals a study published in JAMA Network Open [1].

Technological approaches to drug repurposing for cancer treatment

Generics/Research | Posted 02/04/2021

Cancer is one of the leading causes of death in the world today, causing nearly 10 million deaths in 2018 alone. Despite extensive research into new treatments, when these eventually reach the market, they are often very expensive. The strategy of drug repurposing is being applied to identify already approved drug products as potential cancer therapies. This can bring new cancer treatments to patients faster and at a lower price. A review, published in Signal Transduction and Targeted Therapy [1], summarizes approaches used for drug repurposing and discusses the main barriers to uptake.