Generics/Research

Impact of measures to encourage generics prescribing in Scotland

Since 2000, measures have been introduced in Scotland in order to encourage use of generic rather than brand-name proton pump inhibitors (PPIs) and statins [1]. The impact of these measures on the prescribing practices in Scotland has been positive. Generics use has increased, and costs for the Scottish government have decreased.

Prescribing of generic PPIs and statins in Scotland

In Scotland, a series of measures have been introduced since 2000 in order to encourage use of generic rather than brand-name proton pump inhibitors (PPIs) and statins [1]. Some of the measures introduced include:

Data publication may address generics misperceptions

Wider publication of bioequivalence, safety, or efficacy data to demonstrate the effectiveness of generic drug compounds may help to nullify the last remaining anti-generics argument: that generics do not achieve the same therapeutic standards as the original branded drug.

Factors important for generics substitution in Finland

What factors do patients take into account when deciding to accept or reject generics substitution? This is the question asked in a recent research article [1].

Generics market to experience strong growth in 2010–2017

The global market for generic drugs will experience strong growth in the coming years due to patent expiries of blockbuster drugs worth US$150 billion between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper generics.

Translational research to uncover new uses for generics

On the surface, generic compounds and translational medicines could not appear more different. However, in April 2011, the US National Institutes of Health (NIH) met with academic, governmental, and industry R & D experts to discuss whether translational methods could help to rescue and re-position certain generics [1].

Generics saved US$931 billion over last 10 years

On 21 September 2011, the US Generic Pharmaceutical Association (GPhA) released the results of an independent analysis showing that the use of generic drugs in the US has saved patients and the healthcare system US$931 billion between 2001 and 2010.

Generic atorvastatin may be better than Crestor

AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin) failed to show a statistically significant benefit over Pfizer’s Lipitor (atorvastatin), according to results of a phase IIIb trial. The results could prove to be good news for generics manufacturers, boosting sales of generic atorvastatin, soon to compete with Crestor.

Tendering for medicines in ambulatory care

Tendering is a mechanism whereby a purchaser buys medicines from the pharmaceutical manufacturer that offers the best bid [1]. Whereas tendering is widely used in the hospital sector, it is only recently being rolled out in ambulatory care in an increasing number of countries with a view to constraining pharmaceutical expenditure. Denmark, Germany and The Netherlands are the countries that have taken up the idea most readily. However, the success of this strategy is not yet clear compared to other European generic medicines pricing policies.

Integrated prescriber dispensing can slow generic growth

Countries such as China, Japan and Taiwan which have public health insurance systems, and which allow physicians to both prescribe and dispense drugs themselves, are the most resistant to generics competition, according to a study by two Taiwanese health economists from the National Cheng-Kung University and Academia Sinica, Taipei, Taiwan [1].

Does switching to generic anti-epileptic drugs lead to loss of seizure control

Patients with epilepsy may have a higher risk of seizures if they switch from their brand-name medication to generic anti-epileptic drugs (AEDs). This is the message often heard from clinicians when expressing their concern over generic versions of narrow therapeutic index (NTI) drugs, one class of which is those used to manage the symptoms of epilepsy.

Switching from a brand-name antiepileptic drug to a generic is not associated with a higher risk of seizures

A report in Clinical Pharmacology and Therapeutics provides further evidence that patients with epilepsy do not have a higher risk of seizures if they switch from their brand-name anti-epileptic drugs (AEDs) to the generic version [1].

How successful is the reference pricing system in Belgium

The main aim of a reference pricing system (RPS) is to provide generic medicines at the lowest cost to the state and individuals. This article explains how RPSs work and asks how the Belgian system might be improved to better fulfil its main objective.

Benefits of generics called into question

The benefits associated with generic prescription drugs have been called into question in an article published in the British Medical Journal (BMJ) [1].

Epilepsy: medical concerns of prescribing generics

Generic economics

Generic medications are generally cheaper than their branded product counterparts and so prescribing these is encouraged as a cost-containment strategy in the management of healthcare resources. Encouraging the use of generic drugs is widely considered to be the most simple and effective way of reducing medication expenditure.

Perception of generic drugs as fake among Pakistani immigrants

Pakistani immigrants in Norway may confuse generic drugs with counterfeit drugs, according to research carried out by Norwegian researchers [1].

Generic warfarin as safe and effective as brand name

In a literature study by Dr Francesco Dentali and colleagues found that generic warfarin was as safe as brand name warfarin (Coumadin) [1].

Pakistani immigrants may confuse generics with counterfeit drugs

A study by Norwegian researchers showed that generics substitution may lead to lack of compliance in Pakistani immigrants in Norway, due to misconceptions and confusion with counterfeit drugs [1].

Influence these two factors and the use of generics will increase

According to Assistant Professor William Shrank of Harvard Medical School, Boston, USA, we may be able to increase the use of generic alternatives over brand-name medications if we influence the following two factors: communication about generics between patients and their physicians or pharmacists and the patients’ comfort with generic substitution.

Factors that influence generic drug use

Increasing efforts to influence both the prescriber and patient factors involved in determining the type of initial prescription may benefit everyone involved in paying for medications to get the most cost-effective treatment for their condition.

Savings to be made and compliance with generic antidepressants

Vlahiotis A et al. compared discontinuation rates and healthcare utilisation costs among patients using brand-name versus generic antidepressants.

No difference between generic and brand-name antidepressants

Patients who start treatment for depression with generic drugs benefit from significantly lower costs and are just as likely to keep taking their medication as those who start on brand-name medicines new research suggests.

The ‘Wise List’ - a Swedish drug formulary

Research carried out by Lars Gustafsson and et al. [1] into the use and acceptance of a drug formulary used in Stockholm, Sweden, found that adherence to the ‘Wise List’ resulted in substantial cost savings due to increased use of cheaper generic drugs.

Benefits and risks of generic substitution

According to the FDA, each year, Americans save an estimated US$8–10 billion by purchasing generic drugs rather than branded medications. These savings are, of course, the key advantage of generics. However, the very reason for these cost savings—the fact that generic drugs do not have to undergo the large, expensive clinical trials that are required for approval of branded drugs—gives rise to questions about the quality and safety of generics.

Savings due to generic substitution in South Africa

A retrospective analysis of medical claims for antidepressants during 2004–2006 in South Africa calculated potential savings of 9.3% of the actual antidepressant cost over the study period.

Compliance with generic drug use among Pakistani immigrants

Patients using antihypertensives, antidiabetics or cholesterol-lowering drugs were interviewed using a questionnaire in the study which investigated the perceptions of generic substitution among Pakistani immigrants in Oslo, Norway, and how this affected compliance with their long-term drug use and may be affected by confusion of generic drugs with counterfeit drugs [1].

The benefits of generic substitution

Recent research carried out by Drs Lewek and Kardas, showed that generic drugs are equally as safe and effective as their brand-name equivalents. Patient compliance and cost were also found to be better with generics compared to brand-name drugs.

Different routes for generics and brand-name drugs

Comparison of the route to market generics and brand-name drugs was discussed by Dr Lewek and Dr Kardas in their recent research paper on the benefits and risks of generic substitution.

The status of generic substitution in South Africa

In South Africa only around 13% of the population live in what we would call ‘first world’ conditions. More than half the population (around 48 million people) live in developing world conditions according to researchers from the School of Pharmacy at the North-West University, South Africa.

Generic substitution generates savings in South Africa

Savings of 9.3% over the 3-year study period could have been made with generic substitution of antidepressants according to research carried out by the School of Pharmacy at the North-West University, South Africa.

Generic substitution rates in South Africa

Research carried out by the School of Pharmacy at the North-West University, South Africa, has shown that generic substitution rates for antidepressants increased between 2004 and 2006. Meanwhile antidepressant use decreased over the same period while the average cost decreased in 2005, but increased again in 2006.

Bioequivalence of generic cyclosporine

A clinical trial in allogeneic stem cell transplant (ASCT) recipients found that generic and branded cyclosporine could be considered interchangeable.

Value-based pricing – the concept

The concept of value-based pricing (VBP) is outlined. A key purpose of the VBP system is to assess over time whether the drug has achieved its intended goal and justified its cost.

Efficacy and tolerability of generic and branded atorvastatin

In a study carried out in Korean patients the efficacy and tolerability of generic and branded atorvastatin was evaluated and found to be similar in Korean patients at high risk for cardiovascular events.

Generic substitution in Norway

Using a dataset extracted from the Norwegian prescription database containing all prescriptions written in the period January 2004 to June 2007, an analysis was carried out on two brand-name and two generic statin drugs used to treat high cholesterol and showed that prices have a clear impact on generic substitution [1].

Impact of generic substitution in Finland

Mandatory generic substitution was introduced in Finland on 1 April 2003. A recent study compared the impact of generic substitution on both originator and generic pharmaceutical companies in Finland.

Generic substitution causing confusion

How do customers and pharmacists really experience generic substitution? This is the question asked in a recent research article [1].

Generic and branded acetylcysteine bioequivalent

A single-dose study of acetylcysteine 600 mg found that three tablets of 200 mg of the generic formulation given orally were bioequivalent to a single 600 mg tablet of the branded drug.

The clinical equivalence of brand-name beta-blockers and their generic counterparts

The healthcare systems of the world are all under pressure to reduce costs and using generic substitution for the initially prescribed, more expensive equivalents is an obvious area to investigate. However, as a report reiterated in 2010, treatment decisions should not be based on economic grounds alone, for this would not be in the patient's best interest and would therefore be unethical. What is needed is an opinion based on the evidence available regarding therapeutic equivalence [1].

The rise in power of generic drugs

With shrinking pipelines, the impending expiration of many drug patents, and the global economic downturn experienced in the last two years causing prescription payers to face budget cuts, generic drugs are becoming an increasingly large player in the economics of the global pharmaceutical industry.

Generic or brand-name drugs for cardiovascular disease? Does the evidence match current opinion?

Cardiovascular drugs constitute a large proportion of outpatient prescription drug spending.

Are generic diuretics clinically equivalent to their brand-name counterparts for the management of cardiovascular disease?

Prescription costs are rising, mainly due to brand-name drugs recouping their investment during the period of patent protection and market exclusivity. For this reason, many payers and prescribers encourage use of the cheaper generic versions [1]. This has been found to have another positive consequence, namely the increased accessibility to prescription treatments and an increased compliance with drug regimens, particularly in the case of chronic conditions [2, 3].

The clinical equivalence of generic and brand-name calcium channel blockers

Companies seeking to launch a generic drug are required to submit a dossier to authorities, which does not contain the results of extensive preclinical and clinical testing demonstrating safety and efficacy in the target population, as is the case with novel drugs, but only limited data and evidence demonstrating the fundamental premise that the generic is bioequivalent to its brand-name counterpart.

The therapeutic equivalence of antiplatelet agents, ACE-inhibitors, statins and alpha-blockers

The potential changes in pharmacy formulary policy, due to the availability of generic versions of cardiovascular drugs, should be based on as much evidence as possible.

The therapeutic equivalence of brand-name and generic narrow therapeutic index (NTI) cardiovascular drugs

There are many physicians and patients who have concerns that the bioequivalent generics may not have an equivalent nature in terms of their clinical effect and benefit. In the realm of cardiovascular disease, this can include such parameters as heart rate, blood pressure and laboratory measurements.

International trends in generics: the EU

Few studies have conducted an international price comparison of generic medicines as it is hard to access comparable data. A 2007 study by Prof. Dr. Steven Simoens examined national pricing policies in some EU countries and related them to generics prices (see Table 1).

Medicines pricing policies in Europe: a review

The OECD countries spent 4.6% more per capita per year on pharmaceuticals from 1995 to 2005 although the annual average economic growth was only 2.2% during the same period [1].

The generic drug wars: deeply discounted medication

Fierce competition among major pharmacy chains in the US, such as CVS, Walgreens and Walmart, has led to a generic prescription pricing war with unclear public health implications.

Brand loyalty, generic entry and price competition in the US

In a new working paper from the US National Bureau of Economic Research researchers investigated brand loyalty, generic entry and price competition in the 25 years since the 1984 Waxman-Hatch legislation came into force.

Canadians pay almost twice as much as Americans for generics

A new study released on 13 October 2010 by the Canadian Fraser Institute finds that Canadians pay far higher prices, in fact almost double, for generic drugs than patients in the US.

Comparison of biosimilar and branded vancomycin

Despite demonstrating pharmacological equivalence, researchers have found biosimilar vancomycin exhibited inferior antimicrobial activity compared with the branded product.

Incentives to use generic medicines

A variety of financial and non-financial incentives are intended to encourage generic prescribing. Physician budgets are used by Germany and UK and seem to encourage generic prescribing. Assistance in terms of electronic prescribing, medicines databases, audit and feedback on prescribing data, guidelines and formularies tend to be voluntary and have a limited impact. Denmark and the UK teach medical students to prescribe by INN rather than brand name. Portugal requires prescription by INN if a generic product exists. Physicians see this as a restriction on their prescribing freedom in Belgium and France and resist such moves.

An industry view of generic manufacturing

Research and development of innovative medicines are becoming more challenging, with only 29 medicines with new chemical entities launched in 2006. The dwindling pipeline of new innovative medicines reduces the number of new chemical entities that can be developed when patents on innovative medicines expire in the future. Manufacturers of innovative medicines attempt to extend the period of patent protection by either launching a new dosage, a sustained-release version, a new indication, a single isomer version or a combination medicine. These strategies delay the market entry of generic medicines. As generic competition primarily takes place in the market for prescription medicines, some manufacturers of originator medicines have switched their medicines from prescription to over-the-counter status, e.g. simvastatin 10 mg in UK.

Pricing strategies in generic medicines

Eighty two per cent of countries impose pricing regulation while 18% opt for free market competition to control prices. Of the countries that regulate prices, 36% set the price of generic medicines at a predetermined percentage below the originator price. For instance, the minimum price difference between originator and generic medicines was 20% in Italy in 2004. In 21% of countries, the generic medicine price is based on the average price of medicines in a selection of countries. Other mechanisms used to set generic medicine prices are a maximum price (19% of countries) and a negotiable price (12% of countries).

Can we have our cake and eat it?

Managing the cost of pharmaceutical expenditure is entirely the competence of individual EU Member States. As a result, Europe has developed into a patchwork of different systems of pharmaceutical pricing and reimbursement.

Bioequivalence testing for generics

Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of most generic drug formulations. In general, bioequivalence testing provides a useful comparison for different products containing the same active ingredient. Bioequivalence studies therefore play a key role in the development of new generic products as well as in the post-marketing phase of innovator products.

Are generic medicines in Europe too expensive?

by Professor Steven Simoens, Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven, Leuven, Belgium

Teva CEO about opportunities in generics and biosimilars

To retain its position in the long run, Teva Pharmaceutical Industries Ltd. aims at significant growth in the generic market in the years to come, says Teva CEO Mr Shlomo Yanai in an interview by Mr Haim Watzman published in Nature Medicine in March 2010.

Indian firms seek a higher profile in biosimilars

As reported by Anju Ghangurde in Scrip News of 13 January 2010, large Indian companies appear to be keen to develop their capacities and capabilities in the biosimilars segment, an area expected to take centre stage globally in the coming years. Some of this growing interest is being attributed to the projected decline in the global pipeline for generic small molecules by about 2013, as well as optimism that some large markets such as the US will soon put in place regulations to facilitate the entry of biosimilars.

Physicians still have concerns about the quality, reliability and interchangeability of certain generic medicines

In a study by Dr Mohamed Azmi Hassali et al. of the Universiti Sains Malaysia (USM), as published in the January 2010 Journal of Generic Medicines issue (published online 1 September 2009), physicians’ views on generic medicines are reviewed.

Opportunities and challenges to implementing the Quality by Design approach in generic drug development

In an article by Dr Ramaji Varu of Biocon, Bangalore, India, and Dr Amit Khanna of Novartis, Hyderabad, India, published in the January 2010 Journal of Generic Medicines issue (published online 17 November 2009) the opportunities and challenges to implementing the Quality by Design (QbD) approach in generic drug development are discussed.

European patients trust generic medicines

In total 2,800 patients participated in the European Health study by InSites Consulting. Seven out of ten participants indicated the ability to differentiate generic medicines from brand medicines. While generic medicines contain the same active ingredients as patented brands, we still discovered that 44% of patients who claim to be familiar with generic medicines do not believe this. However this does not detract from the effectiveness patients ascribe to ‘white products’. Eighty three per cent believe that generic medicines are equally effective as the original formula.

Switching statins in Norway after new reimbursement policy

Norwegian scientists assessed the changes in statins prescribing in Norway after implementation of the new reimbursement regulations for statins in June 2005, as published in the British Journal of Clinical Pharmacology of October 2007 by Ms Solveig Sakshaug of the Norwegian Institute of Public Health in Oslo.

Possible economic benefits from generic and therapeutic statin substitution

The group of Associate Professor O Klungel of Utrecht University, The Netherlands, assessed the potential annual savings due to generic and therapeutic substitution of statin therapy for the general Dutch population, taking the patients’ medical histories into account. Pearl Gumbs and colleagues published the study in the British Journal of Clinical Pharmacology in November 2007.

Brand-name drugs are not more effective than generic versions for treating cardiovascular disease

A recent review in Evidence-Based Medicine by Dr Braden Manns of the University of Calgary in Canada studies the question whether generic drugs are as effective as brand-name drugs for treating cardiovascular disease.

Big pharmaceutical firms start to embrace generics

President Barack Obama recently posed an existential question to those around him. “If there’s a blue pill and a red pill, and the blue pill is half the price of the red pill and works just as well, why not pay half the price for the thing that’s going to make you well?” Thus he captured one of two powerful global trends forcing pharmaceutical giants to look for a new business model.

International comparison of generic medicine prices

The introduction of generic price-regulated systems in many European countries, the trend towards international generic medicine companies, and competition from Indian companies emphasises the need to gain insight into international prices of generic medicines.

European generic prescribing trends and biosimilars

Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies is fuelling the development of generic medicines markets in ambulatory care in Europe.

Branded cardiovascular drugs not better than generics

In December 2008, the Journal of the American Medical Association published an article on the clinical equivalence of generic and brand-name drugs used in cardiovascular disease by Aaron Kesselheim, et al. of Harvard Medical School, Boston, MA, USA.