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].