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.