Generics

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].

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. 

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. 

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.

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.

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.

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.

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.

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.

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].