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Generics/Research

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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].

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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].

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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].

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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.

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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].

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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.

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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.

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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.

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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.

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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].

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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.

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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.

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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.

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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].

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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].

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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].

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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.

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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].

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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.