Generics/Research

Adherence to generic versus brand-name statins and associated clinical and economic outcomes

Generics/Research | Posted 24/05/2019

Despite evidence supporting the efficacy of statins for the treatment and prevention of cardiovascular disease, a lack of adherence to statin treatment continues to be a major problem. Sicras-Mainar and colleagues investigated real-world treatment persistence and medical possession for generic versus brand-name statins used in routine clinical practice, and assessed associated clinical and economic outcomes [1].

Costs and prices of entecavir to treat Hepatitis B

Generics/Research | Posted 25/03/2016

In an analysis of the costs and target prices of Hepatitis B treatment entecavir, author Andrew Hill from Liverpool University, UK and colleagues from Imperial College London, UK and Howard University, Washington DC, USA investigated how use of generics is affecting the cost of Hepatitis B treatment around the world [1].

Mixed beliefs about generics among patients in a Malaysian hospital

Generics/Research | Posted 03/05/2019

The Malaysian Government is heavily subsidizing public healthcare expenditure in order to provide access to health care for all citizens. In 2017, total healthcare expenditure in the country was approximately 9.4% of the annual budget. In order to overcome the increasing cost of health care, the government has implemented a National Generic Medicine Policy in 2006 to promote healthier competition in medicine pricing and to make medicines more affordable to the general public. After 10 years of policy implementation, authors from the Ministry of Health Malaysia assess patients' beliefs about generics.

Market evolution of new drug formulations

Generics/Research | Posted 01/04/2019

Brand-name drug manufacturers sometimes create modified versions of their approved drugs which can include new strengths, dosage forms, or delivery routes. This product modification can meaningfully increase patient treatment options; however, some cases have come under scrutiny as they do not offer any clear therapeutic advantages. This second practice is a form of ‘product hopping’, a method used by manufacturers to prolong revenue streams related to market exclusivity. Complementary strategies such as product discontinuation can augment the impact of product hopping.

Factors associated with increased side effects and lower perceived efficacy when switching to a generic

Generics/Research | Posted 22/03/2019

In 2017, the New Zealand Pharmaceutical Management Agency (PHARMAC) changed the funded version of the antidepressant venlafaxine from Efexor XR (the branded originator) or Arrow-Venlafaxine XR (a generic version) to a new generic, Enlafax XR. MacKrill and Petrie examined differences in preferences and perceptions between patients switched from the originator branded venlafaxine to the new generic, and those switched from the old generic version [1]. Specifically, they investigated the factors associated with preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic.

Escalating prices of generic drugs in the US

Generics/Research | Posted 15/03/2019

Generic prescription drug prices have been escalating rapidly in the US. In 2014, generic drug prices increased by 38% on average. Public outcry has led to a flurry of legislative proposals, and two federal bills were introduced in 2017 to improve price transparency and identify drugs exhibiting outlier ‘price spikes’, however, both remain unenacted. In the first three months of 2018, 53 drug pricing transparency bills were initiated in 23 state legislatures.

The 700-dollar vitamin: excessive generics prices in the US

Generics/Research | Posted 01/03/2019

Authors from Johns Hopkins University School of Medicine discuss excessive prices for generics in the US, using vitamin K₁ as an example [1].

Impact of generic reference pricing on candesartan and rosuvastatin use in South Africa

Generics/Research | Posted 15/02/2019

Researchers from South Africa and The Netherlands investigated the effect that generics and generic reference pricing has on candesartan and rosuvastatin use in South Africa [1].

Safety of brand-name and generic angiotensin II receptor blockers

Generics/Research | Posted 18/01/2019

Authors of a study carried out in Canada found that there is still uncertainty regarding generics substitution of angiotensin II receptor blockers (ARBs) [1].

Effectiveness of chronic hepatitis C treatment using direct-acting antivirals: real-life data

Generics/Research | Posted 30/11/2018

Hepatitis is an inflammation of the liver and can be caused by medications, toxins, severe alcohol use and other medical conditions. Hepatitis can also be caused by viruses, most commonly hepatitis A, B and C. Both hepatitis A and B can be dangerous, but there are effective vaccines against both viruses, however, there is no vaccines for hepatitis C [1].

Higher generics use results in higher Medicare Part D star ratings

Generics/Research | Posted 16/11/2018

A study conducted by researchers from Auburn University and IMPAQ International has found that Medicare^# Part D* prescription plans with higher generics use have higher summary star ratings and improved member experience [1].

Ensuring a stable supply of APIs in Japan

Generics/Research | Posted 09/11/2018

A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). It is also indispensable for promoting the use of generics, because API distribution issues can lead to generics shortages. For instance, of the 46 drug shortage problems that arose in FY2013, 21 were associated with API shortages [1]. These shortages can result in a perception among medical staff and patients that generic drugs are unreliable. Therefore, minimizing the risk of API shortage is crucial for promoting the use of generics.

Individual pathways for development of complex generics

Generics/Research | Posted 02/11/2018

The downside of having clear regulatory standards for approval of pharmaceuticals, according to Rodrigo Cristofoletti from Brazil’s Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), is the overuse of one-size-fits-all (OSFA) approaches [1]. Although such approaches ensure harmonization throughout the regulatory decision-making process, they may not be adequate for all cases, and especially not in the case of complex generics.

Platelet reactivity with generic and brand-name clopidogrel

Generics/Research | Posted 19/10/2018

The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. However, there is a lack of information about inhibition of platelet reactivity by generic preparations. A study was therefore carried out using both generic and brand-name clopidogrel to compare the platelet reactivity [1].

Free prescriptions do not always increase use of generics

Generics/Research | Posted 12/10/2018

One strategy to increase the use of generics is to offer them free of charge. This strategy presumes that this will shift demand away from expensive brand-name drugs and produce savings for insurers and customers alike. In order to test this theory, researchers from the University of Maryland studied co-payment data from Medicare recipients^# to see if offering zero generic co-pays for oral antidiabetic drugs (OADs) and statins increased generics use among low-income subsidy (LIS) patients with diabetes.

Limited distribution networks found to be anticompetitive

Generics/Research | Posted 05/10/2018

Limited distribution networks, whereby a drug manufacturer has a contract with one or a small number of distributors, suppress competition in both the generic and biosimilar drug markets. This leads to high costs for both payers and patients, according to a recent US review [1].

Generic hepatitis drug effective in patients with or without HIV

Generics/Research | Posted 28/09/2018

Over 3% of people with hepatitis C infections also have HIV. A new study conducted in Taiwan shows that generic versions of the hepatitis C treatment Epclusa are equally effective in patients with and without HIV co-infection [1].

Factors influencing the use of trade and generic names

Generics/Research | Posted 21/09/2018

Using trade names for drugs in clinical practice has been shown to increase the use of brand-name drugs. Despite efforts by academic medical centres to teach generic drug names and discourage the use of trade names to reduce bias and contain costs, usage of trade names persists. In order to determine what factors might influence healthcare professionals to prescribe by brand-name or generic name, researchers from Stanford University School of Medicine carried out an analysis of medication pages [1].

Hospital use of generic drugs increases adoption by community pharmacies

Generics/Research | Posted 14/09/2018

A recent Japanese study reveals that hospital adoption of generic drugs can also promote their use by community pharmacies. The researchers found that hospital adoption of generic drugs increased community pharmacy dispensation by almost 10% in only a year, reducing overall medical costs [1].

Product recalls increase with increasing generics competition

Generics/Research | Posted 24/08/2018

Generics price competition may lead to relaxed manufacturing standards and ultimately lower quality products, according to a study carried out by researchers from three US universities.

Patient sociodemographics and use of generics

Generics/Research | Posted 20/07/2018

Researchers from the US have found that poorer patients are more likely to use generics [1].

Generic sofosbuvir and daclatasvir bioequivalent to originators

Generics/Research | Posted 13/07/2018

With the aim of eliminating hepatitis C (HCV) by 2030, some originator pharmaceutical companies have granted voluntary licences to generics companies to mass produce the direct-acting antivirals (DAAs) sofosbuvir and daclatasvir at low cost. In order to achieve this, generics makers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originators. Therefore, researchers carried out a study to determine whether generics of sofosbuvir and daclatasvir had bioequivalent pharmacokinetics to the originators [1].

Generic clopidogrel non-inferior to Plavix in acute coronary syndrome

Generics/Research | Posted 29/06/2018

A team of Canadian researchers have concluded that generic clopidogrel is non-inferior to the originator drug, Plavix (clopidogrel), in the treatment of patients with acute coronary syndrome [1]

Doctors’ perceptions of generics in Guadeloupe and Martinique

Generics/Research | Posted 15/06/2018

Doctors in Guadeloupe and Martinique are not hostile towards generics but still mostly prescribe brand-name drugs due to patient preferences, according to a study analysing the perceptions of doctors towards generics in the French speaking territories [1].

Generics market failures and non-profit manufacturing

Generics/Research | Posted 08/06/2018

Competition usually keeps the price of generics well below that of brand-name drugs. However, when there is little or no competition, generics makers can substantially increase prices, which may lead to drug shortages. One way to address such market failures could be to introduce a non-profit generics maker to the market, according to researchers from Intermountain Healthcare, the Johns Hopkins Carey Business School and the Johns Hopkins Bloomberg School of Public Health [1].

Antitrust activities in the pharmaceutical industry

Generics/Research | Posted 01/06/2018

High prices of prescription drugs have been highlighted as reducing access to essential drugs and have recently gained notoriety and political attention. Authors from Harvard Medical School and the law schools of the Northeastern and Rutgers Universities explain the role of antitrust law in restoring competition and restraining price increases [1].

Encouraging generics could cause high prices

Generics/Research | Posted 25/05/2018

A provision introduced in October 2017 awards eligible drugmakers 180 days of exclusivity to market a generic version of one of a list of 267 medicines for which no generic version currently exists. The provision was introduced to encourage generics of off-patent drugs without generics, however, some believe it could lead to high prices [1].

Trends in use of Lipitor after introduction of generic atorvastatin

Generics/Research | Posted 04/05/2018

Big savings can be made after the introduction of generics, especially when it comes to high volume categories, such as statins. Pfizer’s Lipitor (atorvastatin) was the best-selling drug of all time until it lost its patent protection at the end of June 2011 [1] and a generic version became available in the US in November 2011 [2]. However, the impact of the introduction of generics on use of Lipitor is not known. Therefore, researchers from Duke and Yale Universities analysed trends in use and expenditures associated with Lipitor after generic atorvastatin became available [3].

Switchback rates between generic and brand-name drugs

Generics/Research | Posted 20/04/2018

A study carried out by researchers from Harvard Medical School found a lower rate of switchback when patients were switched to an authorized generic from the brand-name product rather than when they were switched to another generic drug product [1].

Portugal increases use of generics for treatment of cardiovascular diseases

Generics/Research | Posted 06/04/2018

In Portugal, the use of medicines for cardiovascular system increased nearly two-fold between 2000 and 2010. As such, over a quarter of the overall expenditure on medicines during these years went towards the treatment of cardiovascular issues [1]. However, it is possible that there may be room for cost saving on these medicines through increased uptake of generic and essential medicines. A recent study by Gama et al. has outlined the trends in outpatient cardiovascular medicine use in Portugal between 2004 and 2012, with focus on the uptake of generic and essential medicines [2].

Pharmaceuticals and products liability litigation

Generics/Research | Posted 30/03/2018

In 2016, healthcare spending represented 17.9% of the economy of the US, a slight increase from 2015. By 2016, the average consumer in the US expended US$1,100 per capita on prescription drugs. Authors Katie McCarthy and Richard Hunter discuss the interconnections between the different types of product liability claims related to marketing and manufacturing of drugs in the pharmaceutical industry, rising drug costs, the increasing availability of generics in the marketplace. They also discuss several major cases and the outcomes of those cases as they relate to the social responsibility of drug manufacturers [1].

Portugal saves money with increased use of cardiovascular generics

Generics/Research | Posted 23/03/2018

Cardiovascular diseases are the primary cause of mortality worldwide [1-3], accounting for over 30% of all deaths. However, in the last few decades, the number of deaths attributed to cardiovascular diseases in higher-income countries has been on the decline. This is thought to be largely due to improved and increased healthcare interventions, according to Gama et al. [4].

Barriers to HIV generics in the US

Generics/Research | Posted 16/03/2018

Combination antiretroviral therapy (ART) has dramatically improved survival rates among people with HIV and is a mainstay of HIV prevention. Generic ART medications offer the potential for treating and preventing HIV at a lower cost [1].

Bioequivalence of brand-name and two generic tacrolimus in transplant patients

Generics/Research | Posted 09/03/2018

Although the US Food and Drug Administration’s (FDA) generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated scepticism of the generics approval process. Three areas of concern are that the pharmacokinetic properties of generic and brand-name products in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and brand-name products may not ensure bioequivalence between generics and high-risk patients may have specific bioequivalence concerns. While this study tests tacrolimus, the novel trial design and results may globally impact regulatory considerations and strategies, not only for the approval of immunosuppressants but also for other narrow therapeutic index/ critical dose drugs.

Adverse outcomes for elderly using generic versus brand-name ARBs

Generics/Research | Posted 02/03/2018

Generics are commercialized once active ingredient’s patent of a brand-name drug expires. Brand-name to generics substitutions are encouraged and favoured due to the considerable savings for both patients and payers. Comparative bioavailability studies ensure pharmacokinetic equivalence between a given brand-name drug and corresponding generics, with similar requirements worldwide. However, no clinical equivalence studies are required before generics commercialization. After commercialization, few studies have assessed outcomes between brand-name and generic drug users in cardiology, especially at a population level.

Persistence with generic imatinib in CML patients

Generics/Research | Posted 23/02/2018

A study carried out by researchers from Canada investigated the clinically comparability of brand-name and generic imatinib in patients treated for chronic myeloid leukaemia (CML) [1].

Efficacy and safety of generic imatinib after switching

Generics/Research | Posted 15/02/2018

A study carried out by researchers from the US investigated switching from originator to generic imatinib in patients treated for chronic myeloid leukaemia [1].

Approval rating and opinion on generic drugs in Italy: a cross-sectional study in the Liguria region

Generics/Research | Posted 09/02/2018

Italy has the lowest generics market share by volume in Europe (less than 20%), coming just below Portugal and Spain. While in Northern European countries the introduction of generics took place between the 1970s and 1980s, in Italy the concept of generics was only clarified in 1996 (law n. 425) and physicians were only required to inform patients from 2012 [1].

Interchangeability of gabapentin generics

Generics/Research | Posted 02/02/2018

Researchers from The Netherlands and the US developed a model that could describe pharmacokinetic data for generic gabapentin in order to identify potential subpopulations of individual patients with increased risk for altered pharmacokinetics [1].

Treatment of chronic myeloid leukaemia patients with generic imatinib in Algeria

Generics/Research | Posted 19/01/2018

In a developing country like Algeria expensive therapies are not available. Alternative approaches are needed. In Algeria Imatib (imatinib: CIPLA-India) was introduced in 2006; however, no study has been published yet in the North Africa region regarding response and outcome of this generic drug in chronic myeloid leukaemia (CML) patients. Therefore, researchers from the Service d’Hématologie in Algeria and France carried out a multicentre study in newly diagnosed adult CML patients in the western region of Algeria. The aim of the study was to assess the effectiveness and safety of Imatib as a frontline therapy for patients with CML [1].

The Greek problem of generics pricing

Generics/Research | Posted 12/01/2018

Over the past few decades spending on prescription pharmaceuticals has increased faster than total health spending and gross domestic product in most OECD (Organisation for Economic Co-operation and Development) countries [1, 2].

Jan Aushadhi and affordability and accessibility of medicines in India

Generics/Research | Posted 05/01/2018

The pharmaceutical industry in India ranks third in the world in terms of volume and 14th in terms of value. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the total turnover of India’s pharmaceutical industry between 2008 and September 2009 was US$21.04 billion. Hyderabad, Mumbai, Bangalore, Visakhapatnam and Ahmedabad are the major pharmaceutical hubs of India. The domestic market was worth US$13.8 billion in 2013.

Generics substitution of antiretroviral drugs in Ireland: patient views

Generics/Research | Posted 26/05/2017

Researchers in Ireland report the findings of a survey of opinions on the generics substitution of antiretroviral (ARV) drugs [1], revealing that over 70% of patients would have no concerns about their use.

Generic metformin bioequivalent in healthy volunteers in Nigeria

Generics/Research | Posted 01/12/2017

Researchers from Nigeria’s Obafemi Awolowo University have found generic metformin sourced in the country to be ‘not inferior’ to originator metformin [1].

Perceptions and attitudes towards generics in South Korea

Generics/Research | Posted 24/11/2017

A survey of the perception and attitude of South Korean physicians towards generics has shown that not much has changed despite the introduction of a new pharmaceutical policy in 2012 [1].

Mergers could be causing price increases for generics

Generics/Research | Posted 10/11/2017

How mergers and acquisitions in the generics sector can be a factor in drug shortages and increasing prices was a question addressed by researchers from Carleton and McGill Universities in Canada [1].

New use for old generic could treat rare cardiovascular condition

Generics/Research | Posted 03/11/2017

Researchers from Canada and the UK may have found a new use for an old generic drug: treatment of the rare cardiovascular condition, pulmonary arterial hypertension (PAH).

Perceptions of generic drugs in Latin America: a Guatemalan case study

Generics/Research | Posted 27/10/2017

A recent assessment of generic drug use in Guatemala [1] revealed a widespread lack of trust in generics, due to a combination of poor quality, powerful advertising campaigns and limited state regulation.

Challenges in the rediscovery of old generics

Generics/Research | Posted 13/10/2017

Finding new treatment options by repurposing generics is a cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics there are multiple obstacles standing in the way [1].

Repurposing thioguanine

Generics/Research | Posted 06/10/2017

Repurposing and re-registering old generics is a cost-effective and time-efficient way of finding new purposes for existing drugs. One such ‘old generic’ that has been repurposed and re-registered is thioguanine [1].

Repurposing and re-registering old generics

Generics/Research | Posted 29/09/2017

Finding new indications for existing drugs is better known as drug rediscovery, drug repurposing or drug repositioning. It is cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics, the lack of a formal regulatory pathway for such drugs and a lack of economic interest by pharmaceutical companies, makes it a challenging pursuit [1].

Barriers to generics substitution in the Middle East

Generics/Research | Posted 01/09/2017

Although most pharmacists in Lebanon are in favour of generic drug substitution, fewer than half have actually implemented the policy, according to a study carried out by researchers from the American University of Beirut [1].

Generic drug substitution in Lebanon

Generics/Research | Posted 25/08/2017

A new study reports on Lebanon’s recently introduced generic drug substitution and unified prescription policy, a country which spends among the most on pharmaceuticals in the Middle East. The study explored attitudes of community pharmacists towards the idea of the policy and its current implementation [1].

Generics prices increase when competition decreases

Generics/Research | Posted 11/08/2017

A US-based retrospective cohort study has found that generics prices increase when competition is low or non-existent [1].

Follow-up study finds generic tacrolimus safe for kidney transplant patients

Generics/Research | Posted 14/07/2017

Researchers from Portugal, who carried out a long-term follow-up study, have found that switching stable kidney transplant patients to generic tacrolimus is safe [1].

Generics in the pipeline for 2017 in the US

Generics/Research | Posted 07/07/2017

Since the Hatch-Waxman Act was passed in 1984, the approval process for generics has been simplified. The law created an abbreviated approval pathway for generics making it easier for generics to enter the market and expanding access to important — often life-saving — drugs.

Oncology drug pricing – the case of generic imatinib

Generics/Research | Posted 09/06/2017

Authors Christopher Chen and Aaron Kesselheim review how various market strategies slowed the entry of generics of leukaemia treatment Gleevec (imatinib) in the US [1].

Generic substitution of antiretroviral drugs in Ireland: healthcare provider views

Generics/Research | Posted 02/06/2017

A survey conducted in Ireland shows that most healthcare providers consider the generic substitution of antiretroviral drugs acceptable, although concerns remain about dosing frequency [1].

Reference pricing for generics in Switzerland

Generics/Research | Posted 04/05/2017

In 2016, the Swiss Federal Office for Health (FOH) planned to modify the reference pricing scheme for generics. Rather than using a copayment of 10 per cent on low-cost and a 20 per cent copayment on high-cost generics, it was to set the benchmark at the 25th percentile of the price distribution and make patients pay out of pocket for the full excess of price over this benchmark in addition to a basic 10 per cent copayment. This paper, based on an expert report commissioned by Intergenerika, the Swiss association of manufacturers and importers of generics and biosimilars, purports to answer the question of whether this modification is apt to improve the performance of the Swiss healthcare system [1].

Approaches to assure quality and improve patient perceptions of generics in Japan

Generics/Research | Posted 28/04/2017

The rapidly ageing population in Japan has led the government to promote the use of generics in the universal health insurance system. This article provides an overview of the regulatory approaches available to confirm the quality of generics and achieve greater acceptance of these products by patients [1].

Significant price reductions possible for new cancer drugs

Generics/Research | Posted 21/04/2017

Generic production could drastically reduce the prices of novel cancer drugs and make treatments accessible to thousands more people each year, according to a study by Hill et al. [1].

Generics could cut costs of cancer drugs by over 99%

Generics/Research | Posted 14/04/2017

Generics manufacturing and import of novel cancer drugs could massively reduce their costs in the UK, according to a study by Hill et al.[1].

Evolution of scientific research on generic drugs

Generics/Research | Posted 31/03/2017

A review of peer-reviewed scientific articles carried out in January 2013 on generic drugs published on PubMed/MEDLINE from the date of the first published article on generics (1954) to 2012 was undertaken by Lucas-Dominguez et al. (2016) to establish the current status of research in this area. According to the authors, this is the first study to evaluate evolution of research on generic drugs.

Potency of generics of piperacillin/tazobactam

Generics/Research | Posted 24/03/2017

In an era of increasing bacterial resistance, the potency of antibiotics is critical. Researchers from the Tata Medical Centre, Kolkata, India tested the relative potency of different generic brands of the piperacillin/tazobactam antibiotic [1].

Delaying generics using citizen petitions

Generics/Research | Posted 17/03/2017

A study of citizen petitions submitted to the US Food and Drug Administration (FDA) over the last 12 years finds that such petitions are being used by drug companies ‘in a last-ditch effort to hold off competition’ [1].

Promoting and regulating generics in Brazil

Generics/Research | Posted 10/03/2017

Generic drug substitution constitutes a core instrument of countries’ strategies to reduce the price of drugs and expand access to health care. To that end, scholars and international organizations have encouraged adoption of a range of policy instruments that countries can use to promote the use of generics, focusing on measures to increase both the demand for and supply of such products.

Rising costs of cancer treatments not matched by clinical efficacy

Generics/Research | Posted 03/03/2017

The high prices of new cancer treatments are a major barrier to access in low-income countries and placing growing pressure on developed countries. In their study, author Hill et al. estimated the lowest possible treatment costs for four new cancer drugs, showing that manufacturing of generics alternatives could significantly reduce treatment costs [1].

Generics and brand-name drugs compared

Generics/Research | Posted 17/02/2017

What differentiates generics from brand-name medications? That is a question that Andrea Bakker from the Faculty of Medicine of the University of Ottawa tried to answer [1]. In her commentary she explored how differences in licensing affect drug efficacy and how the pharmaceutical landscape in Canada affects patient care.

Switching stable kidney transplant patients to generic tacrolimus safe

Generics/Research | Posted 10/02/2017

Researchers from Chile have found that switching stable kidney transplant patients to generic tacrolimus is safe. However, they caution the transplant community to carefully monitor any switch to generics [1].

Patent and regulatory exclusivities driving generic and follow-on market availability

Generics/Research | Posted 03/02/2017

Daniel Nam reviews the differences between intellectual property exclusivity (patents) and regulatory exclusivities (market exclusivity) in the US [1]. A patent is a grant of property right to an inventor for 20 years from the date of application. Market exclusivity is awarded to manufacturers of first-to-market brand products and excludes other manufacturers from marketing the drug product for a certain period of time, depending on the type of product. Nam explains that these tools are used by the US Food and Drug Administration (FDA) to achieve a balance between innovation and equitable access to medications.

Addressing patient misconceptions about generics

Generics/Research | Posted 02/12/2016

In the face of increasing drug costs, substitution by generics is often used as a strategy by healthcare systems to rein in expenditure. However, patient misconceptions about generics can hinder such substitutions. Researchers Sanchez and Zurek discuss how pharmacists can improve this situation by educating patients on the use and safety of generics [1].

Policies to address price rises in old generics

Generics/Research | Posted 25/11/2016

Old, off-patent drugs are becoming increasingly expensive. But how can policymakers address the problem? Naren P Tallapragada from the Harvard Medical School discusses the underlying causes of the high-cost off-patent drug problem and proposes some policy solutions that could address the problem [1].

Combating shortages and price increases in the US generics market

Generics/Research | Posted 26/02/2016

As a result of recent price increases and shortages, the US generics market has come under increasing scrutiny [1]. In a recent report by Wiske et al. authors from Brown, Duke and Harvard Universities discussed ways to increase the competitiveness of the US generics market that might address these problems [2].

Therapeutic substitution could save Americans US$73 billion

Generics/Research | Posted 18/11/2016

Therapeutic substitution could save the America healthcare system US$73 billion and patients US$24.6 billion in out-of-pocket expenses, according to US researchers [1].

Transparency in the Australian pharmaceutical industry

Generics/Research | Posted 11/11/2016

In Australia, the promotion of medicines to healthcare professionals is controlled by self-regulatory schemes operated by the pharmaceutical industry.

Factors affecting generics entry

Generics/Research | Posted 04/11/2016

Edward Kong, Research Assistant at the Yale University, Department of Economics, carried out a study into the factors that influence a generics maker’s decision to enter a specific market [1].

Cost-effectiveness analysis and incentivizing innovation

Generics/Research | Posted 27/05/2016

In the paper by Santiago Moreno and Joshua Ray, the controversial role that conventional cost-effectiveness analysis (CEA) plays in incentivizing innovation is revealed [1]. Detractors criticize its use for pricing purposes because it disregards the value of innovation brought by new drugs, while supporters argue that it is already accounted for. The objective of the paper is to identify the limitations of the conventional CEA approach and to propose an alternative that offers a more realistic estimate of the true value of innovation.

Perceptions of the value of generics in Brazil

Generics/Research | Posted 20/05/2016

Generics were first approved in Brazil in 1999. Substitution of generics and reference drugs can occur at the time of purchase and upon patients’ request, and, in the public healthcare system, physicians must prescribe drugs by their Brazilian Common Denomination (Denominação Comum Brasileira – DCB). However, despite legislation that supports their prescription, generics still have a small market share, representing only 27.3% of all drug units sold in Brazil in January 2014. A potential reason for the low penetration of generics into the Brazilian market is a negative perception of the value of generics.

Substitution of generic antiepileptic drugs

Generics/Research | Posted 15/04/2016

Despite the availability of generic antiepileptic drugs (AEDs), patients and neurologists still hesitate to make a switch due to several reasons.

Impact of South Korea’s new drug–pricing policy on market competition

Generics/Research | Posted 01/04/2016

In April 2012, the Korean Government implemented a new policy to try and make its multiple sourced (off-patent) market more competitive. Their objective was to lower the price of generics through increased competition. The government in this way also aimed to reduce the costs for both patients [who have typically a 30% co-payment in ambulatory care (20% in hospitals)] and the National Health Insurance. The core of the policy was to establish the same maximum reimbursement price, i.e. the same ceiling price, for both the originator (brand-name) and the generic drug. This was expected to make the market more competitive, with generics manufacturers competing with each other to gain market share by lowering their prices. However, other professionals argued that this policy would still favour originators, given the general belief that an originator medicine, which is often from an international pharmaceutical company, would be better quality.