Generics/Research

Right of appeal provision in CETA

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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_max 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

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

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

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

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

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

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

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

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

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

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

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].

Changes in risperidone use in Austria after introduction of generics

Currently, many governments have introduced austerity reforms to control pharmaceutical expenditure. In Austria, efforts have been made to both increase the use and lower the prices of generics. The problem is that antidepressants are not like other drugs, such as cholesterol-reducing medicines, where switching from originators to generics is not seen as a problem. For antidepressants the patient’s treatment is often tailored to meet their specific needs and there is resistance to switch products in stable patients.

Use of venlafaxine in Austria after introduction of generics

Trying to reduce expenditure on medicine is a major driving force for reforms by many governments. This includes Austria, where measures have been introduced to lower generics prices and enhance their use. However, the situation for newer antidepressants and atypical antipsychotic medicines (AAPs) is different to proton pump inhibitors (PPIs) (anti-reflux), statins (cholesterol-reducing), and renin-angiotensin inhibitor (blood-pressure reducing) drugs. For antidepressants therapy, it is more often tailored to meet the patient’s needs and there is resistance to switch products in stable patients.

Patients’ knowledge and perceptions about generics in Australia

Most Australians know about generics but are not sure if they prefer brand-name or generic drugs, according to a survey carried out by Australian researchers and published in December 2012 in the Journal of Pharmacy Practice and Research [1].

Generics policies in Europe have room for improvement

In Europe, generics policies have not yet been implemented to their full extent, according to authors Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference [1, 2].

Conflict-of-interest policies reduce brand-name prescribing

Psychiatrists who are exposed to conflict-of-interest (COI) policies during their residency are less likely to prescribe brand-name antidepressants after graduation than those who train in residency programmes without such policies, according to a new study by researchers from the Perelman School of Medicine at the University of Pennsylvania, USA [1].

HIV generics could significantly cut treatment costs

The US Government could save almost US$1 billion in the first year alone by using generic rather than brand-name drugs for the treatment of HIV patients, according to a study published in the Annals of Internal Medicine [1].

Overview of research on regulatory issues for generics in 2012

Period: January to August 2012 

Regulatory issues are a challenge facing generics of all kinds, and one that may limit the competitiveness and sustainability of the generics industry. However, with the cost of medicines becoming a more and more important factor for patients and the healthcare industry as a whole there is a need for both harmonization of regulatory requirements between different regions, e.g. Canada, EU and US, as well as a need for clarity in the regulatory requirements for certain generics.

Brand-name and generics labels don’t match

According to US federal law generics manufacturers have to have the same labelling as their brand-named counterparts. However, a new study has found that in practice this is often not the case.

Patent cliff winners and losers

During 2011 and 2012 a whole host of patents have expired on many blockbuster drugs. In fact it was estimated that in 2012 US$33 billion of sales would be lost due to the patent cliff [1].

US pharmacists positive about generic drugs

Pharmacists, prescribers and patients often voice concerns about the safety and efficacy of generic drugs when they are substituted for brand-name drugs. Results of a survey, reported by Ms Laurie Scudder, shows that pharmacist and prescriber opinions on generic drugs in the US are generally positive, see Figure 1.

Overview of research on ‘specific’ policies aimed at generics in 2012

Period: January to August 2012 

Countries around the world have embraced generics due to their cost-saving potential. Many governments already have policies in place to promote the use of generic medicines, and as health systems face continuous cost pressures and demands to invest in new technologies, generics can only become more important.

Safety and efficacy of generic tenofir/lamivudine/efavirenz combination

New research shows the safety and efficacy of a generics combination of tenofir, lamivudine and efavirenz in the treatment of HIV-infected patients in Thailand [1].

Black-box safety warnings and the future of generic drug liability

Generic medicines currently have no responsibility for adding warnings about adverse effects of their medicines. Despite the US Supreme Court ruling that it was ‘impossible’ to force generics manufacturers to update their labels with the latest warnings, many feel that they have an ethical responsibility to do just that [1].

Overview of research on ‘general’ policies aimed at generics in 2012

Period: January to August 2012 

Many governments around the world already have policies in place to promote the use of generic medicines, and with the increasing cost of health care and restrictions on budgets the need for low cost, quality medications can only become more important.

The ethics of generic drug liability

What responsibility should the manufacturers of generic medicines bear for warnings about adverse effects of their medicines? Indeed, what responsibility should be borne by the original manufacturers of these drugs? What happens if an adverse effect is noticed after the drug has been in use for many years? Such questions are being pondered in the US after a recent ruling in which the Supreme Court decided it was ‘impossible’ to force generics manufacturers to update their labels with the latest warnings.

History and future of pay-for-delay

Pay-for-delay is a constant issue in both the US and Europe. But how did these settlements first come about and how have US courts attitudes towards such deals affected the pharmaceutical market [1].

Overview of clinical research on generics in 2012

Period: January to August 2012 

Generic drug alternatives to brand-name prescription medications are becoming increasingly important in the global drug market as governments strive to contain healthcare costs and as an increasing number of prescription drugs lose patent protection.

Suggestions for increasing generics use in Abu Dhabi

This concluding article in a series of three suggests ways of improving the use of generics in Abu Dhabi.

Use of generics in Abu Dhabi

The second of three articles examining how to increase generics use in Abu Dhabi.

Maximising the potential of generics in Abu Dhabi

Introduction
All residents in Abu Dhabi have access to health care via mandatory health insurance. Nationals, who comprise 20% of the population with two-thirds under 30 years of age and half under 19 years of age, have automatic access to comprehensive health care funded by the government. In 2008, all nationals received cards giving free access to health care and choice of provider in both the public and private sectors [1].

Misunderstandings regarding generics in Pakistan

This article is the third of three articles covering the results of a survey investigating the knowledge, perception and attitude of general practitioners (GPs) towards generic medicines in Karachi, Pakistan [1].

Facts about generics for patients

The costs of health care are rising across Europe through ageing populations resulting in more patients with chronic diseases, stricter clinical targets for managing patients with long term (chronic) diseases, the continued launch of new and more expensive drugs as well as rising patient expectations.

Attitude of general practitioners towards generics in Pakistan

The second of a series of three articles reports on a survey aimed at exploring the knowledge, perception and attitude of general practitioners towards generic medicines in Karachi, Pakistan [1].

Generics in Pakistan

This is the first of a series of three articles on the problems facing Pakistan in making health care affordable to ordinary people.

Management of drugs shortages

The number, range and duration of drug shortages in the US appear to be, at best, maintaining the levels seen in the recent past. It is now becoming essential for institutions to draft formal policies and procedures to manage them. An article by two hospital pharmacists summarises the information available and outlines the steps needed to make the best of the situation [1].

Attitudes and beliefs are powerful influences on generics use

While generic drugs have the potential to provide significant savings in healthcare costs, and numerous financial incentives are in place, the generics substitution rate in Switzerland was, until recently, lower than expected. A report by Decollogny et al. shows that attitudes and beliefs among patients and physicians have a powerful influence on prescribing practice, suggesting that educational campaigns could potentially provide a significant boost to generics use [1].

Efficacy and tolerability of generic and brand-name atorvastatin

A generic formulation of atorvastatin was developed in Korea and approved by Korea Food and Drug Administration on 1 July 2008. This clinical trial was conducted at ten clinical centres in Korea between September 2008 and May 2010 for the purposes of marketing the generic formulation [1].

Increased use of generic statins proves cost effective in Australia

A recent study concluded that closing the statin ‘treatment gap’ using generics was cost-effective in the secondary prevention of coronary artery disease (CAD) in Australia [1].

Can generic competition succeed at reducing cost of atorvastatin?

The generic form of the cholesterol-lowering drug Lipitor (atorvastatin) has the potential for significant cost savings for payers following its introduction in November 2011. However, ‘aggressive business tactics’ by Pfizer may stifle generics competition and so prevent prices from falling as much as predicted.

Comparison of brand-name and biosimilar etanercept in Korea

A study comparing pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg) in Korea reported by Gu et al has shown that the reference drug and the test biosimilar met the standard criteria for assuming bioequivalence as defined by Korean regulatory authorities [1].

Cheap generic drug stops fatal bleeding but gets little use

According to a systematic review of data, use of a cheap generic drug could potentially save many trauma patients every year [1].

Patients do not talk about generics with doctors

One of the main financial concerns expressed by adults in the US is the cost of medications and medical bills, however, despite this fact, very few patients talk about the price of prescription medicines with their physicians, according to Consumer Reports' monthly nationally representative survey [1].

Attitudes towards prescribing generics in Malaysia

A recent study carried out in Malaysia has shown that pharmacists in the country have a lack of confidence in generic medicines produced by local pharmaceutical companies [1].

Brand-name atorvastatin cheaper than generics

Despite generics of Pfizer’s blockbuster cholesterol-reducing drug Lipitor (atorvastatin) being available in the US since the patent expired in November 2011, many patients are still receiving the brand-name drug [1].

Cost savings due to prescribing of generic PPIs and statins in Scotland

Significant cost savings can be made by governments by encouraging prescribing of generics rather than brand-name drugs. In Scotland, in an effort to control medicines expenditure, measures were introduced in 2000 to encourage the prescribing of generic proton pump inhibitors (PPIs) and statins [1].