Generics/Research

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].