Generics/Research
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.
European patients trust generic medicines
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.
Switching statins in Norway after new reimbursement policy
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.
Possible economic benefits from generic and therapeutic statin substitution
The group of Associate Professor O Klungel of Utrecht University, The Netherlands, assessed the potential annual savings due to generic and therapeutic substitution of statin therapy for the general Dutch population, taking the patients’ medical histories into account. Pearl Gumbs and colleagues published the study in the British Journal of Clinical Pharmacology in November 2007.
Brand-name drugs are not more effective than generic versions for treating cardiovascular disease
A recent review in Evidence-Based Medicine by Dr Braden Manns of the University of Calgary in Canada studies the question whether generic drugs are as effective as brand-name drugs for treating cardiovascular disease.
Big pharmaceutical firms start to embrace generics
President Barack Obama recently posed an existential question to those around him. “If there’s a blue pill and a red pill, and the blue pill is half the price of the red pill and works just as well, why not pay half the price for the thing that’s going to make you well?” Thus he captured one of two powerful global trends forcing pharmaceutical giants to look for a new business model.
International comparison of generic medicine prices
The introduction of generic price-regulated systems in many European countries, the trend towards international generic medicine companies, and competition from Indian companies emphasises the need to gain insight into international prices of generic medicines.
European generic prescribing trends and biosimilars
Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies is fuelling the development of generic medicines markets in ambulatory care in Europe.
Branded cardiovascular drugs not better than generics
In December 2008, the Journal of the American Medical Association published an article on the clinical equivalence of generic and brand-name drugs used in cardiovascular disease by Aaron Kesselheim, et al. of Harvard Medical School, Boston, MA, USA.
