Generics/Research

FDA awards grant to study generic transplant drug tacrolimus

Generics/Research | Posted 22/11/2013

The US Food and Drug Administration (FDA) has awarded a federal grant worth US$2.3 million to researchers at the University of Cincinnati, Ohio, USA, in order to continue studies into tacrolimus, a drug commonly used to stop rejection in transplant patients.

Price components of pharmaceutical expenditure

Generics/Research | Posted 15/11/2013

In the second of a series of four articles on pharmaceutical expenditure, Vogler and co-authors take a top down approach to the concept of pharmaceutical expenditure and its use as an indicator in healthcare accounting. Here, they look at the differences in outpatient and inpatient price types [1].

Pharmaceutical expenditure as a health-expenditure indicator

Generics/Research | Posted 08/11/2013

Pharmaceutical expenditure is a major indicator in health-expenditure accounting, and is particularly useful to policymakers and researchers in making regional, country and international comparisons, forecasting, and assessing the effect of pharmaceutical policies [1].

Transplant coordinators’ perception of generic immunosuppressants

Generics/Research | Posted 04/10/2013

Transplant coordinators associate the availability of multiple generic immunosuppression therapies with increased patient confusion, according to a study by Parker and co-authors [1].

Use of generic anti-asthmatic drugs in Morocco

Generics/Research | Posted 20/09/2013

Asthma is a serious public health problem in Morocco. However, due to low income and lack of healthcare coverage in the country many of Morocco’s citizens do not have access to anti-asthmatic drugs.

Therapeutic substitution could save Americans money

Generics/Research | Posted 06/09/2013

Substituting more expensive brand-name drugs with generics or therapeutic substitutes, could lead to significant savings for Medicare Part D beneficiaries, according to US researchers [1].

Strategies used by sickness funds to increase generics prescribing in Austria

Generics/Research | Posted 30/08/2013

In 2010, a survey of Austrian sickness funds was undertaken to evaluate how Austrian doctors, patients and pharmacists are encouraged to enhance the rational use of medicines, and increase use of generics [1].

Interchangeability of gabapentin generic formulations in The Netherlands: summary of a comparative bioavailability study

Generics/Research | Posted 23/08/2013

Abstract 
The registration of generic formulations in the EU is governed by regulatory authorities in the respective European countries. Before a generic drug can be registered, bioequivalence to the branded formulation has to be demonstrated, i.e. 90% confidence intervals of area under the curve (AUC), and Cmax should fall within the 80–125% acceptance range. Comparative studies with other generics are not required. In order to establish whether a generic medicine is interchangeable with other generic formulations under current regulations, the Dutch regulatory authority conducted a single- dose, four-way crossover comparative bioavailability study with four gabapentin formulations, i.e. the branded formulation and three generic drugs, as test medication. The results showed that all four formulations were bioequivalent to each other, and that no interchangeability issues would result from switching.

How regional sickness funds in Austria encourage more rational prescribing

Generics/Research | Posted 16/08/2013

In Austria, as in other EU countries, rational use of medicines is high on the healthcare agenda. According to WHO, use of generic medicines help reduce costs incurred by public payers and is a way of supporting rational use of medicines.

Implications of the changes in venlafaxine utilization in Sweden following generics

Generics/Research | Posted 16/08/2013

Godman and co-authors review the changes in the utilization of venlafaxine post generics. This includes the limited influence on utilization post generics with no specific demand-side measures. This changed following prescribing restrictions for duloxetine. However, influence limited by the need to tailor treatments for patients with depression [1].

The cost of evergreening strategies

Generics/Research | Posted 09/08/2013

The practice of evergreening, where pharmaceutical companies make small patentable changes to existing products with soon-to-expire patents, contributed to increased healthcare costs in Switzerland, according to a study by authors from the University of Geneva and Geneva University Hospitals [1].

Use of brand-name drugs increasing healthcare costs in US

Generics/Research | Posted 02/08/2013

Patients with diabetes who are covered by the US healthcare insurance Medicare are two to three times more likely to use expensive brand-name drugs compared to patients treated within the Veterans Affairs Healthcare System [1].

FDA grant to study generic versus brand-name transplant drugs

Generics/Research | Posted 16/11/2012

FDA has given a grant to the University of Cincinnati, Ohio, USA, in order to support a study into a commonly used immunosuppressive drug for transplant patients, tacrolimus.

Generic antiepileptic drugs bioequivalent to brand-name drugs

Generics/Research | Posted 24/01/2013

Results of a study, reported by Dr Ravi Juluru and co-authors at the American Epilepsy Society’s 66th Annual Meeting, held in San Diego, USA on 30 November–4 December 2012, shows that generic slow-release drugs for seizure disorders are ‘equivalent’ to their brand-name counterparts [1].

Generics combo non-inferior to treatment with Enbrel

Generics/Research | Posted 05/07/2013

A study carried out by researchers from the US Department of Veterans Affairs and the Canadian Institutes for Health Research has found that a combination of three generic drugs is non-inferior to treatment with Amgen’s blockbuster biological Enbrel (etanercept) [1].

Innovation in the generics industry

Generics/Research | Posted 10/05/2013

The decrease in innovation in the originator pharmaceutical industry is leading to an increase in innovation in the generics pharmaceutical industry, according to new research [1].

Quality of generics in South Africa

Generics/Research | Posted 29/04/2013

A study of the quality of generic medicines in South Africa has shown large differences in the perception and the actual quality of generics [1].

Cost savings from use of generic medicines in Ireland

Generics/Research | Posted 12/04/2013

Ireland has one of the lowest usages of generics in the EU. However, in order to try to address this, the country introduced a new bill – Health (Pricing and Supply of Medical Goods) Bill 2012 – on 16 September 2012. Authors Dunne et al. discuss how the proposed changes could affect health care in Ireland [1].

Use of generic medicines in Ireland

Generics/Research | Posted 29/03/2013

Ireland’s Department of Health and Children intends to introduce a system of reference pricing and generics substitution in Ireland, which will greatly increase the utilization of generics and generate significant cost savings, whilst at the same time, increasing the accessibility and affordability of essential medicines. Authors Dunne et al. discuss Ireland’s history with the use of generic medicines [1].