Generics/Research

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.