Generics/Research

Right of appeal provision in CETA

Generics/Research | Posted 14/08/2014

The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1], with certain provisions being seen as causing the most harm.

Data protection provisions in CETA

Generics/Research | Posted 01/08/2014

The trade agreement between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1]. In particular, certain intellectual property provisions are seen as the main culprits.

Patent term restoration provisions in CETA

Generics/Research | Posted 04/07/2014

Some of the provisions included in the Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada are seen as having the potential to have a negative affect on the generics industry in Canada [1].

Influence of CETA on generics

Generics/Research | Posted 27/06/2014

On 18 October 2013, the European Union (EU) and Canada reached a political agreement on the key elements for a Comprehensive Economic and Trade Agreement (CETA). However, CETA has been criticized for the fact that it affects intellectual property rights in Canada, but not the EU. Some of the provisions included in the agreement are seen as having the potential to have a negative affect on the generics industry in Canada.

Factors influencing use of generic asthma drugs in Morocco

Generics/Research | Posted 20/06/2014

Despite the introduction of methods to promote the use of generics, use of generic anti-asthmatic drugs remains limited in Morocco. The Moroccan market therefore remains largely dominated by patent-protected originator drugs [1].

Promoting generics prescribing in the UK

Generics/Research | Posted 13/06/2014

Possible ways to encourage more prescribing of generics in the UK include financial incentives with educational intervention and audit/feedback, according to a review of data on prescribing behaviour [1].

Impact of price cuts on spending on hyperlipidaemic drugs in South Korea

Generics/Research | Posted 06/06/2014

Rapidly increasing pharmaceutical expenditures have become a constant challenge to the sustainability of healthcare systems across countries including Korea.

Generic atypical antipsychotic drugs in Belgium

Generics/Research | Posted 02/06/2014

Health authorities are continually looking to increase the utilization of low cost generics to save considerable monies without compromising care, given the ever increasing pressure on available resources. Pressures are driven by ageing populations, the continual launch of new premium-priced drugs and stricter clinical management targets. The quest is enhanced by the number of standard drugs losing their patents in recent years.

Impact of delisting ARBs in Denmark

Generics/Research | Posted 23/05/2014

Health authorities are looking to increase the utilization of low cost generics to save considerable resources without compromising care. This includes Denmark [1].

Pharmacists’ attitudes towards generics in Czech Republic

Generics/Research | Posted 16/05/2014

A study carried out in the Czech Republic found that whether pharmacists routinely carried out generics substitution depended on their familiarity with the relevant legislation and their attitude towards generics substitution [1].

Attitudes towards generics in Turkey

Generics/Research | Posted 02/05/2014

Prescribers, pharmacists and patients in Turkey lack knowledge about generics. They may also be misinformed about generics, which can cause hesitation about the use of these drugs, according to Toklu and co-authors from the University of Istanbul, Turkey [1].

Free samples increase use of branded drugs

Generics/Research | Posted 25/04/2014

The practice of giving free samples to physicians to give out to their patients increases the use of brand-name drugs, according to research published in JAMA Dermatology [1].

Positive impact of a value-based approach to health care

Generics/Research | Posted 18/04/2014

A study into the use of value-based benefit design (VBBD) for members of an employee health benefits programme demonstrated that such a programme can have a positive impact on adherence and cost outcomes [1].

Prescribers, pharmacists and patients in Turkey believe generics differ from originators

Generics/Research | Posted 04/04/2014

A study carried out by Toklu and co-authors from the University of Istanbul, Turkey, has shown that many prescribers, pharmacists and patients in Turkey believe that generics differ from their originators [1].

The non-financial benefits of generics substitution

Generics/Research | Posted 28/03/2014

Switching between different generic brands of metformin is a good cost-effective approach that does not adversely affect the quality of care for patients with type 2 diabetes, according to the results of a retrospective study in Taiwan.

Generics contribution to availability of essential medicines

Generics/Research | Posted 14/03/2014

The creation of Essential Medicines Lists (EMLs) within country healthcare systems is promoted by the World Health Organization (WHO) in order to improve the availability and use of medicines considered essential.

Use of generic cardiovascular drugs in China

Generics/Research | Posted 07/03/2014

China has not yet recognized the importance of increasing generics use as a method to reduce drug prices. An analysis of drug prices in hospitals in the Chongqing province in China has shown that there are potentially major savings to be made by increasing the volume of generics used in China [1].

Compliance and persistence same for generic and brand-name alendronate

Generics/Research | Posted 28/02/2014

A retrospective analysis of data in Italy has shown that patients taking generic and brand-name alendronate showed the same rates of persistence and compliance [1].

Confusion exists in Brazil over generics

Generics/Research | Posted 21/02/2014

Brazilians are confused about generics and are unable to distinguish between a generic drug and a brand-name drug [1].

Impact of coupons on adherence to statins

Generics/Research | Posted 14/02/2014

Once patents expire, in an effort to maintain market share, originator manufacturers often initiate promotional activities such as drug samples and co-pay discount coupons that reduce patients out-of-pocket costs associated with the purchase of brand-name drugs.

Effects of income, competition and procurement on drug prices in emerging markets

Generics/Research | Posted 07/02/2014

Drugs are least affordable relative to income in low-income countries, according to an analysis of income, competition and procurement on drug prices in emerging markets [1].

Access to medicines in Shaanxi province China

Generics/Research | Posted 31/01/2014

Although generics in the Shaanxi province of China are significantly cheaper than their brand-name equivalents there is still room for improvement, according to a study of the prices and availability of selected medicines in the province [1].

Switching to generic cyclosporine A after heart transplant safe

Generics/Research | Posted 24/01/2014

Cyclosporine A is an immunosuppressant drug widely used in organ transplantation to prevent rejection. A study of switching between originator and generic drugs showed that the generic was well tolerated and that there were no differences between the originator and generic drugs [1].

Recent reforms and initiatives in Scotland to encourage the prescribing of generic drugs and the implications

Generics/Research | Posted 13/12/2013

Scotland has introduced a number of reforms and initiatives in recent years to enhance the prescribing of low cost generics, thereby saving money to help fund increased volumes and new premium priced drugs [1, 2]. However, there have been situations where no specific initiatives have been introduced [3, 4]. Consequently, analysis of the various initiatives in Scotland could provide examples to other countries seeking additional measures to further enhance their prescribing efficiency.

Understanding pharmaceutical expenditure

Generics/Research | Posted 06/12/2013

In the previous three articles by Vogler and co-authors price and volume components of pharmaceutical expenditure were discussed. In the final article of the series, some of the methodological challenges that can be faced in interpreting and analysing expenditure data are addressed and the challenges faced by the authors’ own survey of pharmaceutical expenditure data across European Union Member States are discussed [1].

Volume components of pharmaceutical expenditure

Generics/Research | Posted 29/11/2013

In the third of a series of four articles on pharmaceutical expenditure, Vogler and co-authors explain the different methodological approaches to measuring pharmaceutical utilization and outline some of the volume-control policies in place across Europe [1].

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 C_maxshould 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].