Generics/Research

Generic clopidogrel non-inferior to Plavix in acute coronary syndrome

Generics/Research | Posted 29/06/2018

A team of Canadian researchers have concluded that generic clopidogrel is non-inferior to the originator drug, Plavix (clopidogrel), in the treatment of patients with acute coronary syndrome [1]

Doctors’ perceptions of generics in Guadeloupe and Martinique

Generics/Research | Posted 15/06/2018

Doctors in Guadeloupe and Martinique are not hostile towards generics but still mostly prescribe brand-name drugs due to patient preferences, according to a study analysing the perceptions of doctors towards generics in the French speaking territories [1].

Generics market failures and non-profit manufacturing

Generics/Research | Posted 08/06/2018

Competition usually keeps the price of generics well below that of brand-name drugs. However, when there is little or no competition, generics makers can substantially increase prices, which may lead to drug shortages. One way to address such market failures could be to introduce a non-profit generics maker to the market, according to researchers from Intermountain Healthcare, the Johns Hopkins Carey Business School and the Johns Hopkins Bloomberg School of Public Health [1].

Antitrust activities in the pharmaceutical industry

Generics/Research | Posted 01/06/2018

High prices of prescription drugs have been highlighted as reducing access to essential drugs and have recently gained notoriety and political attention. Authors from Harvard Medical School and the law schools of the Northeastern and Rutgers Universities explain the role of antitrust law in restoring competition and restraining price increases [1].

Encouraging generics could cause high prices

Generics/Research | Posted 25/05/2018

A provision introduced in October 2017 awards eligible drugmakers 180 days of exclusivity to market a generic version of one of a list of 267 medicines for which no generic version currently exists. The provision was introduced to encourage generics of off-patent drugs without generics, however, some believe it could lead to high prices [1].

Trends in use of Lipitor after introduction of generic atorvastatin

Generics/Research | Posted 04/05/2018

Big savings can be made after the introduction of generics, especially when it comes to high volume categories, such as statins. Pfizer’s Lipitor (atorvastatin) was the best-selling drug of all time until it lost its patent protection at the end of June 2011 [1] and a generic version became available in the US in November 2011 [2]. However, the impact of the introduction of generics on use of Lipitor is not known. Therefore, researchers from Duke and Yale Universities analysed trends in use and expenditures associated with Lipitor after generic atorvastatin became available [3].

Switchback rates between generic and brand-name drugs

Generics/Research | Posted 20/04/2018

A study carried out by researchers from Harvard Medical School found a lower rate of switchback when patients were switched to an authorized generic from the brand-name product rather than when they were switched to another generic drug product [1].

Portugal increases use of generics for treatment of cardiovascular diseases

Generics/Research | Posted 06/04/2018

In Portugal, the use of medicines for cardiovascular system increased nearly two-fold between 2000 and 2010. As such, over a quarter of the overall expenditure on medicines during these years went towards the treatment of cardiovascular issues [1]. However, it is possible that there may be room for cost saving on these medicines through increased uptake of generic and essential medicines. A recent study by Gama et al. has outlined the trends in outpatient cardiovascular medicine use in Portugal between 2004 and 2012, with focus on the uptake of generic and essential medicines [2].

Pharmaceuticals and products liability litigation

Generics/Research | Posted 30/03/2018

In 2016, healthcare spending represented 17.9% of the economy of the US, a slight increase from 2015. By 2016, the average consumer in the US expended US$1,100 per capita on prescription drugs. Authors Katie McCarthy and Richard Hunter discuss the interconnections between the different types of product liability claims related to marketing and manufacturing of drugs in the pharmaceutical industry, rising drug costs, the increasing availability of generics in the marketplace. They also discuss several major cases and the outcomes of those cases as they relate to the social responsibility of drug manufacturers [1].

Portugal saves money with increased use of cardiovascular generics

Generics/Research | Posted 23/03/2018

Cardiovascular diseases are the primary cause of mortality worldwide [1-3], accounting for over 30% of all deaths. However, in the last few decades, the number of deaths attributed to cardiovascular diseases in higher-income countries has been on the decline. This is thought to be largely due to improved and increased healthcare interventions, according to Gama et al. [4].

Barriers to HIV generics in the US

Generics/Research | Posted 16/03/2018

Combination antiretroviral therapy (ART) has dramatically improved survival rates among people with HIV and is a mainstay of HIV prevention. Generic ART medications offer the potential for treating and preventing HIV at a lower cost [1].

Bioequivalence of brand-name and two generic tacrolimus in transplant patients

Generics/Research | Posted 09/03/2018

Although the US Food and Drug Administration’s (FDA) generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated scepticism of the generics approval process. Three areas of concern are that the pharmacokinetic properties of generic and brand-name products in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and brand-name products may not ensure bioequivalence between generics and high-risk patients may have specific bioequivalence concerns. While this study tests tacrolimus, the novel trial design and results may globally impact regulatory considerations and strategies, not only for the approval of immunosuppressants but also for other narrow therapeutic index/ critical dose drugs.

Adverse outcomes for elderly using generic versus brand-name ARBs

Generics/Research | Posted 02/03/2018

Generics are commercialized once active ingredient’s patent of a brand-name drug expires. Brand-name to generics substitutions are encouraged and favoured due to the considerable savings for both patients and payers. Comparative bioavailability studies ensure pharmacokinetic equivalence between a given brand-name drug and corresponding generics, with similar requirements worldwide. However, no clinical equivalence studies are required before generics commercialization. After commercialization, few studies have assessed outcomes between brand-name and generic drug users in cardiology, especially at a population level.

Persistence with generic imatinib in CML patients

Generics/Research | Posted 23/02/2018

A study carried out by researchers from Canada investigated the clinically comparability of brand-name and generic imatinib in patients treated for chronic myeloid leukaemia (CML) [1].

Efficacy and safety of generic imatinib after switching

Generics/Research | Posted 15/02/2018

A study carried out by researchers from the US investigated switching from originator to generic imatinib in patients treated for chronic myeloid leukaemia [1].

Approval rating and opinion on generic drugs in Italy: a cross-sectional study in the Liguria region

Generics/Research | Posted 09/02/2018

Italy has the lowest generics market share by volume in Europe (less than 20%), coming just below Portugal and Spain. While in Northern European countries the introduction of generics took place between the 1970s and 1980s, in Italy the concept of generics was only clarified in 1996 (law n. 425) and physicians were only required to inform patients from 2012 [1].

Interchangeability of gabapentin generics

Generics/Research | Posted 02/02/2018

Researchers from The Netherlands and the US developed a model that could describe pharmacokinetic data for generic gabapentin in order to identify potential subpopulations of individual patients with increased risk for altered pharmacokinetics [1].

Treatment of chronic myeloid leukaemia patients with generic imatinib in Algeria

Generics/Research | Posted 19/01/2018

In a developing country like Algeria expensive therapies are not available. Alternative approaches are needed. In Algeria Imatib (imatinib: CIPLA-India) was introduced in 2006; however, no study has been published yet in the North Africa region regarding response and outcome of this generic drug in chronic myeloid leukaemia (CML) patients. Therefore, researchers from the Service d’Hématologie in Algeria and France carried out a multicentre study in newly diagnosed adult CML patients in the western region of Algeria. The aim of the study was to assess the effectiveness and safety of Imatib as a frontline therapy for patients with CML [1].

The Greek problem of generics pricing

Generics/Research | Posted 12/01/2018

Over the past few decades spending on prescription pharmaceuticals has increased faster than total health spending and gross domestic product in most OECD (Organisation for Economic Co-operation and Development) countries [1, 2].

Jan Aushadhi and affordability and accessibility of medicines in India

Generics/Research | Posted 05/01/2018

The pharmaceutical industry in India ranks third in the world in terms of volume and 14th in terms of value. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the total turnover of India’s pharmaceutical industry between 2008 and September 2009 was US$21.04 billion. Hyderabad, Mumbai, Bangalore, Visakhapatnam and Ahmedabad are the major pharmaceutical hubs of India. The domestic market was worth US$13.8 billion in 2013.

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