Generics/Research

Is India ready to use only generics?

Generics/Research | Posted 18/03/2016

This editorial provides a balanced and neutral perspective of the debate regarding use of brand-name versus generic medicines, from an Indian endocrine point of view. It helps stakeholders arrive at appropriate decisions, using a process of informed and shared decision-making [1].

The satisfaction of healthcare payers, patients and physicians with generic imatinib

Generics/Research | Posted 05/08/2016

With the begining of the era of tyrosine kinase inhibitors (TKIs), chronic myeloid leukaemia (CML) became a chronic disease, in which good responding patients usually have a life expectancy similar to the age- and sex-matched normal population [1]. In many countries, the first-line treatment of chronic phase CML is imatinib mesylate (IM). Whereas, especially in some developed countries, second generation TKIs (dasatinib, nilotinib) which have deeper and faster responses, but are also more expensive than IM, are utilized in the upfront setting. The introduction of TKIs increased the prevalence of CML, and optimal responders to IM should continue therapy indefinitely, so the originator TKI treatment (Gleevec) surely put a strain on healthcare providers even in developed countries.

Competition in the generics industry

Generics/Research | Posted 21/10/2016

In theory, an increase in the use of generics should help to reduce overall drug expenditures. However, growth in spending on medicines in the US increased by US$46.2 billion, or 12.2%, over 2014 levels, reaching US$425 billion in 2015 [1]. This increase comes despite a simultaneous growth in spending on generics, which increased by US$7.9 billion (7.4%) to US$114.1 billion in 2015.

Generic antibiotics could be contributing to bacterial resistance

Generics/Research | Posted 07/10/2016

Therapeutic non-equivalence of generic antibiotics could be contributing to the global problem of bacterial resistance, according to researchers from the Universidad de Antioquia in Colombia.

Different approaches to bioequivalence trials for EMA evaluation

Generics/Research | Posted 23/09/2016

Selection of robust bioequivalence study designs is a difficult task for manufacturers of generics. Author Nathaniel Refalo from the Malta Medicines Authority and colleagues therefore investigated whether different approaches in various products assessed by the European Medicines Agency (EMA) during the approval phase resulted in a reduction in the resources required to show bioequivalence [1].

South Africa’s expedited registration policy not speeding up access to biosimilars

Generics/Research | Posted 16/09/2016

Since South Africa’s National Department of Health (DoH) implemented a fast-track registration policy in 2003 the large number of generics applications has led to a backlog in approvals [1]. This has led to concern that this backlog is having a detrimental effect on patient access to critical pharmaceutical medicines and in particular biosimilars [2].

South Africa’s expedited registration policy for rapid access to critical medicines under threat by generics

Generics/Research | Posted 09/09/2016

In 2003, the National Department of Health (DoH) of South Africa implemented a fast-track registration policy, not only for new chemical entities (NCEs) considered essential for national health and which may not be on the Essential Medicines List (EML) of South Africa, but also for all medicines on the EML, the majority of which are generics [1].

Driving down drug prices: how regulators can influence affordability

Generics/Research | Posted 02/09/2016

In recent years there has been increasing global concern over drug prices and their affordability. And what is the role played by regulators in drug pricing? This is the subject of discussion in a recent paper co-authored by the European Medicines Agency’s (EMA) Executive Director Guido Rasi, its Senior Medical Officer Hans-Georg Eichler, the Executive Director of Dutch Medicines Evaluation Board Hugo Hurts, and the President of the German Federal Institute for Drugs and Medical Devices Karl Broich [1]. Although the price of medicines is not within the regulatory remit, the authors find this an inescapable subject for debate and they outline possible regulatory interventions that could drive down drug prices.

Generics in seizure control

Generics/Research | Posted 26/08/2016

Are generic medicines for the control of epileptic seizures bioequivalent to their brand-name counterparts? Steven Karceski [1] has recently reviewed a study carried out by researchers at the Johns Hopkins University School of Medicine, Baltimore, MD, USA in which they determine the bioequivalence of generic seizure control medications [2].

Ways to reduce drug costs in Australia

Generics/Research | Posted 29/07/2016

Drug costs in Australia are increasing at an alarming rate. This is driven mainly by expensive biological therapies, antiviral therapies for HIV and hepatitis C and new cancer treatments.

AES position statement on substitution of generic anti-epileptics

Generics/Research | Posted 01/07/2016

A paper by the American Epilepsy Society (AES) discusses how the society’s position on generics substitution of anti-epileptic drugs has changed according to the results of bioequivalence studies [1].

Reasons for the success of a generics company in the Sudan market

Generics/Research | Posted 24/06/2016

An exploratory, qualitative study carried out by colleagues from the University of Khartoum (Sudan) and Abertay University (UK) examined the reasons behind the success of a generics company that has been the market leader in Sudan for a decade from the perspective of employees and customers [1].

Pharmacists prefer generic OTC medicines

Generics/Research | Posted 17/06/2016

In the US, the use of generics has been lacking due to hesitation from consumers over whether generics are as safe and effective as brand-name medications. Pharmacists, on the other hand, have the education and training to know that generics are both safe and effective.

Enhancing prescribing efficiency in the Republic of Srpska

Generics/Research | Posted 28/06/2013

It has been claimed that countries with smaller populations have difficulties obtaining considerable price reductions for generics. However, evidence from the Republic of Srpska, which is one of the two constitutive entities of Bosnia and Herzegovina, with a population of only 1.43 million, proves otherwise [1].

Equivalence of generic immunosuppressants

Generics/Research | Posted 31/05/2013

There are no compelling pharmacological arguments against the sensible use of the generic immunosuppressants ciclosporin, tacrolimus and mycophenolate mofetil in clinical practice, argue pharmacologists working in drug evaluation in The Netherlands [1].

Alleviating concerns around generic antiepileptic medications

Generics/Research | Posted 23/11/2012

Reports that some patients with epilepsy were more likely to experience seizures and hospitalisation after switching from brand-name drugs to generic alternatives have led to concerns about generic antiepilepsy drugs (AEDs). A recent review, however, argues that the onset of seizures following a switch may be due more to the disruption of normal routine than the choice of medication. The authors suggest that AEDs are relatively safe and effective compared to innovator drugs.

Switching between generics of anti-epileptic drugs

Generics/Research | Posted 10/06/2016

Two different generic versions of anti-epilepsy medicine lamotrigine have been shown to be bioequivalent in patients with epilepsy and to not cause any differences in seizure frequency or adverse events, according to a study published in the February 2016 online edition of The Lancet Neurology.

Perceptions of the substitution of generics

Generics/Research | Posted 13/05/2016

Pharmacists are mostly positive about the substitution of generics for brand-name drugs, according to a study analysing negative perceptions about generics, carried out by researchers from New Zealand and the US [1].

Perceptions of the safety and side effects of generics

Generics/Research | Posted 06/05/2016

A quarter of doctors believe that generics are less safe and cause more side effects than brand-name drugs, according to a study carried out by researchers from New Zealand and the US [1].

Perceptions of the effectiveness and quality of generics

Generics/Research | Posted 29/04/2016

More than a quarter of doctors and the general public believe that generics are less effective and of poorer quality than brand-name drugs, according to a study carried out by researchers from New Zealand and the US [1].

Generics perceptions in patients, pharmacists and doctors

Generics/Research | Posted 22/04/2016

A significant proportion of the general public, pharmacists and doctors have negative perceptions about generics, according to a study carried out by researchers from New Zealand and the US [1].

Perception and knowledge of generics in Portugal

Generics/Research | Posted 04/03/2016

Patients in Portugal are misinformed about generics, according to researchers from the Bragança Polytechnic Institute [1].

Measures to increase generics use in Greece

Generics/Research | Posted 19/02/2016

Austerity has forced Greece to introduce a number of measures to reduce the amount it spends on healthcare. But how have measures aimed at increasing generics use in the country been perceived by stakeholders? This was a question Karampali and co-authors from the National School of Public Health, Athens, Greece tried to answer [1].

Consumer choice between generic and brand-name medicines in a small generics market

Generics/Research | Posted 12/02/2016

Background
Generics offer an opportunity to governments to contain pharmaceutical expenditures, as they are generally 10‒80% lower in price than the originator brand-name medicines. Belgium has a small generics market, which takes up 15% of the total pharmaceutical market (in packages sold).

Pharmacists’ attitudes towards domestic generics in Afghanistan

Generics/Research | Posted 29/01/2016

The aim of the study by Hassali et al. was to survey community pharmacists regarding their attitudes about the quality and price of locally manufactured medicines [1].

Paediatric use of low-cost generic programs in the US

Generics/Research | Posted 22/01/2016

Low-cost generic drug programs (LCGPs) in the US increase the affordability of prescription medication that can treat many common paediatric conditions. LCGPs are a loss-leader pricing strategy used by eight of the top 10 pharmacy chains, e.g. Walmart, Walgreens, RiteAid, providing generics at co-payments of US$4‒5 for 30-day supplies or US$10‒12 for 90-day supplies. By using these programmes, no information is submitted through an individual’s prescription medication insurance benefit; thus, medication use data can be missing from administrative claims data. This phenomenon has implications for safety surveillance, quality measurement of health plans, and for researchers utilizing these data.

Physicians’ and pharmacists’ perspectives on generics use

Generics/Research | Posted 15/01/2016

The review study of Toverud et al. shows that both physicians and pharmacists have acknowledged strategies for generics use as an attempt to curtail increasing drug expenditures [1]. However, in Northern Europe and in the US health professionals were confident about the generics available, whereas in countries with less mature healthcare systems there were concerns about the manufacturing sources of generics and the companies’ trustworthiness. A general marked variation was also found regarding control routines and bioequivalence requirements between countries with mature healthcare systems and those with developing ones.

Use of generics in cardiovascular diseases

Generics/Research | Posted 08/01/2016

Researchers from Italy and the US carried out a meta-analysis with the aim of comparing the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines [1].

Doctors in the US should remember to prescribe generics

Generics/Research | Posted 15/01/2016

According to the findings of a literature review carried out by the American College of Physicians (ACP) the major obstacle to increased use of generics in the US is patient and provider perceptions.

Pharmaceutical pricing and reimbursement policies

Generics/Research | Posted 11/12/2015

A recurrent challenge in health policy is to ensure equitable access to safe and effective medicines. In recent years, access to medicines, in particular to high-cost medicines, has become a major challenge for payers in all countries including high-income economies. Factors that challenge the financial sustainability of publicly funded health and pharmaceutical systems include demographic and epidemiological developments, a tightening of public health budgets due to overall economic pressures, e.g. the global financial crisis, and the need of public payers to consider covering new medicines, some of which come with premium prices [1].

Prescribing and dispensing generics in Japan

Generics/Research | Posted 27/11/2015

Drug costs in Japan have been found to be much greater than the average of industrialized nations, which means that too many wasteful prescriptions are written for pharmaceuticals. This has been attributed to attempts by medical institutions to increase revenues by prescribing unnecessary medicines to patients. To curb this trend, the government has pushed forward with the lowering of government-set prices for prescription drugs and the separation of medical and dispensary services in its national health programme, which was implemented in 1974.

Policies to lower prices of generics in Austria and Finland

Generics/Research | Posted 04/12/2015

In this era of austerity many governments have introduced policies aimed at reducing the price of generics. In Austria, measures taken to reduce the cost of medicines include generic price linkage. While in Finland generics substitution and reference pricing have been introduced.

Safety monitoring of drug interchangeability

Generics/Research | Posted 20/11/2015

When a brand-name drug is going off patent protection, pharmaceutical or generics companies may file an abbreviated new drug application (ANDA) for approval of a generic drug. As indicated by the US Food and Drug Administration (FDA), two drug products are claimed to be bioequivalent (BE) if the 90% confidence interval (CI) for the geometric mean ratio is totally within the bioequivalent limits of (80%, 125%) based on log-transformed data [1, 2] and an approved generic drug can be used as a substitute for the brand-name drug. FDA, however, does not indicate that approved generics of the same brand-name drug can be used interchangeably. Assume a patient switches the generic drug from BE 125% to BE 80% or from BE 80% to BE 125%, the change of the drug concentration in blood are both dramatic. As more generics become available in the marketplace, it is a concern whether the approved generics are safe and can be used interchangeably.

FDA evaluation of residual solvents in generics

Generics/Research | Posted 13/11/2015

Differences between generics and their reference product in terms of inactive ingredients, e.g. residual solvents, are allowed if applicants provide information demonstrating that these differences do not affect the safety or efficacy of the proposed drug product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by formulation differences between generic and originator drugs [1].

Prescribing generics for chronic musculoskeletal pain

Generics/Research | Posted 06/11/2015

The use of generics has become an issue of concern, both in public health and economical terms. Nevertheless, parallel to an ever-stronger advocacy for their use, various sources of information have reported patients’ concerns regarding substitution. Using a qualitative interview study, researchers from Geneva University Hospitals and the University of Geneva investigated the personal definitions and understanding of generics in patients suffering from non-specific chronic musculoskeletal pain, to elucidate the reasons that might explain why patients are confident or reluctant to take generics [1].

FDA evaluation of impurities in generics

Generics/Research | Posted 30/10/2015

Although generics may differ from their reference product in terms of inactive ingredients, which includes impurities, such compounds in generics, especially genotoxic impurities, are an area of increasing concern for the pharmaceutical and regulatory world. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1].

FDA evaluation of excipients in generics

Generics/Research | Posted 23/10/2015

Generics may differ from their reference product in terms of inactive ingredients, e.g. excipients, provided this does not affect the safety and efficacy of the product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1].

Effectiveness and cost-effectiveness of osteoporosis drugs

Generics/Research | Posted 16/10/2015

Comparison of treatments for osteoporosis has shown that pharmacological intervention for prevention of secondary fractures is cost-effective [1].

Impact of antiretroviral generics on the Italian National Health Service

Generics/Research | Posted 09/10/2015

The cost of antiretroviral therapies (ART) for the treatment of human immunodeficiency virus (HIV), which is now considered a chronic disease [1], represents an increasing burden for healthcare services worldwide. In particular, the availability on the market of new antiretroviral drugs, often more effective and more expensive than those available, lead to the need to identify cost containing strategies to ensure the economic sustainability of the healthcare service and to provide effective treatments to patients. Over the next few years, several patents for antiretroviral drugs will expire, giving the possibility for generics to enter the market. The availability of new generics on the market, may lead to a lowering of ART costs, and therefore to the affordability to provide the aforementioned new and innovative drugs.

Formulation differences between generics and reference products

Generics/Research | Posted 02/10/2015

Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by formulation differences between generic and originator drugs [1].