Eighty two per cent of countries impose pricing regulation while 18% opt for free market competition to control prices. Of the countries that regulate prices, 36% set the price of generic medicines at a predetermined percentage below the originator price. For instance, the minimum price difference between originator and generic medicines was 20% in Italy in 2004. In 21% of countries, the generic medicine price is based on the average price of medicines in a selection of countries. Other mechanisms used to set generic medicine prices are a maximum price (19% of countries) and a negotiable price (12% of countries).
Managing the cost of pharmaceutical expenditure is entirely the competence of individual EU Member States. As a result, Europe has developed into a patchwork of different systems of pharmaceutical pricing and reimbursement.
Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of most generic drug formulations. In general, bioequivalence testing provides a useful comparison for different products containing the same active ingredient. Bioequivalence studies therefore play a key role in the development of new generic products as well as in the post-marketing phase of innovator products.
by Professor Steven Simoens, Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven, Leuven, Belgium
To retain its position in the long run, Teva Pharmaceutical Industries Ltd. aims at significant growth in the generic market in the years to come, says Teva CEO Mr Shlomo Yanai in an interview by Mr Haim Watzman published in Nature Medicine in March 2010.
As reported by Anju Ghangurde in Scrip News of 13 January 2010, large Indian companies appear to be keen to develop their capacities and capabilities in the biosimilars segment, an area expected to take centre stage globally in the coming years. Some of this growing interest is being attributed to the projected decline in the global pipeline for generic small molecules by about 2013, as well as optimism that some large markets such as the US will soon put in place regulations to facilitate the entry of biosimilars.
Physicians still have concerns about the quality, reliability and interchangeability of certain generic medicines
In a study by Dr Mohamed Azmi Hassali et al. of the Universiti Sains Malaysia (USM), as published in the January 2010 Journal of Generic Medicines issue (published online 1 September 2009), physicians’ views on generic medicines are reviewed.
Opportunities and challenges to implementing the Quality by Design approach in generic drug development
In an article by Dr Ramaji Varu of Biocon, Bangalore, India, and Dr Amit Khanna of Novartis, Hyderabad, India, published in the January 2010 Journal of Generic Medicines issue (published online 17 November 2009) the opportunities and challenges to implementing the Quality by Design (QbD) approach in generic drug development are discussed.
In total 2,800 patients participated in the European Health study by InSites Consulting. Seven out of ten participants indicated the ability to differentiate generic medicines from brand medicines. While generic medicines contain the same active ingredients as patented brands, we still discovered that 44% of patients who claim to be familiar with generic medicines do not believe this. However this does not detract from the effectiveness patients ascribe to ‘white products’. Eighty three per cent believe that generic medicines are equally effective as the original formula.
Norwegian scientists assessed the changes in statins prescribing in Norway after implementation of the new reimbursement regulations for statins in June 2005, as published in the British Journal of Clinical Pharmacology of October 2007 by Ms Solveig Sakshaug of the Norwegian Institute of Public Health in Oslo.