Generics/Research

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].

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].

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