The generic medicines system in Italy: scenarios for sustainable growth

Author byline as per print journal: Federico Fontolan1, MA; Silvia Zucconi1, MStat; Carlo Piccinni2, PhD Abstract: In this paper, an overview is provided of the present Italian generic medicines system. Data on generic medicines market share and enterprise performance were reviewed and discussed, and the results of a survey completed by general practitioners (Computer Assisted […]


Adjusted indirect comparisons between generics – bioequivalence and interchangeability

Abstract: Adjusted indirect comparisons are valuable to establish the bioequivalence and thereby the interchangeability between generic drug products. Limitations should be observed especially when several generics of a drug are marketed. Submitted: 14 June 2016; Revised: 23 June 2016; Accepted: 24 June 2016; Published online first: 4 July 2016 A recent review discussed adjusted indirect […]


Assessment of the interchangeability between generics

Author byline as per print journal: Luther Gwaza1,2, BPharm, MPhil; John Gordon3, PhD; Henrike Potthast4, PhD; Marc Maliepaard5, PhD; Jan Welink5, Hubert Leufkens1,5, PhD; Matthias Stahl6, MD; Alfredo García-Arieta7, PhD Abstract: Generic medicines are approved by regulatory authorities based on demonstration of bioequivalence with the innovator, however, direct comparison between all available generics of the […]


Challenges of developing generics substitution policies in low- and middle-income countries (LMICs)

Abstract: There are few challenges to developing effective generics substitution policies in low- and middle-income countries (LMICs). These include the absence of generics substitution policies, lack of enforcement, lack of evidenced-based data about bioequivalence and lack of acceptance by physicians and patients. Submitted: 3 June 2015; Revised: 19 June 2015; Accepted: 24 June 2015; Published […]


Generic medicines entry into the Malaysian pharmaceutical market

Author byline as per print journal: Omotayo Fatokun, PhD; Professor Mohamed Izham Mohamed Ibrahim, PhD; Professor Mohamed Azmi Hassali, PhD Abstract: There are major barriers to generic medicine development and market entry in Malaysia. This mixed method study recommends strategies to increase uptake. Submitted: 25 October 2016; Revised: 15 November 2016; Accepted: 21 November 2016; Published […]


Generic medicines policy in Qatar

Abstract: Qatar’s pharmaceutical market is likely to remain highly dependent on imports. The use of generic medicines remains a great challenge to the country. Submitted: 18 December 2014; Revised: 28 January 2015; Accepted: 1 February 2015; Published online first: 13 February 2015 Qatar is the world’s richest country per capita. The country established its National […]


Analysis of European policy towards generic medicines

Abstract: In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes for delayed market access of generic medicines and the need for policies to accelerate market access. These should work in conjunction with policies designed to […]


Challenges to generic medicines utilization in Yemeni healthcare system

Abstract: Generic medicines are promoted in many countries as an essential part of the healthcare system. However, in Yemen, there are many challenges to the utilisation of generic medicines. Currently, there is no national level policy to enhance or promote generic medicines use. In addition, other challenges to the use of generic medicines in Yemen […]


A review of generic medicine pricing in Europe

Introduction: Switching from originator products to generic equivalents is a key method used by governments to reduce costs and keep their healthcare systems sustainable. The aim of this article is to review generic medicine pricing in Europe by analysing the factors that influence them. Methods: The literature review focused on selected studies that highlighted generic […]