Pharmaceutical Technology Europe - August 2010 - (Page 12)

Clinical and cost considerations of developing a biosimilar Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously. For generics, very limited clinical studies (often only Phase I pharmacokinetic studies) are required, whereas biosimilars require extensive clinical trials, including Phase I and Phase III studies. Thorough consideration will need to be given to the trial design, target population and the reference product in order to prove therapeutic equivalence with adequate confidence. One benefit of the rigorous development of a biosimilar, however, is that in some geographical regions it is possible to extrapolate the findings to other related indications that have not yet been trialled. Under current EU guidelines, certain proteins, such as blood factors, are considered too complex or heterogeneous to qualify for a biosimilar pathway. Consequently, for complex biosimilars some additional trial data may be required regarding the extent and impact of any physicochemical and biological differences, the existence of measurable sensitive endpoints, the clinical relevance of these endpoints to the claimed therapeutic indication and the magnitude of the therapeutic response compared with placebo. “...the size of the trial may even need to be larger than that for the reference product...” endpoint criteria for establishing equivalence, and the trial must also be sensitive enough to detect any clinically meaningful differences. In fact, the size of the trial may even need to be larger than that for The cost of developing a biosimilar There are wide ranges quoted in the literature for the estimated costs of developing small molecule generics, biosimilars and biological products, but according to the Pharmaceutical Research and Manufacturers of America it costs in the region of $1.2 billion to develop a new biologic compared with approximately $375 million and $1.5–4 million for a biosimilar and small molecule generic, respectively. In some instances, the cost of developing and marketing a biosimilar has deterred companies from entering the biosimilars market. However, once approved the manufacturer can apply modern production technology that can cut manufacturing costs by about 70%. In most cases, companies will ultimately target the EU market for product launch because of the more established pathway for 6 THE BIOSIMILARS MARKET 11 IMPACT ON INNOVATION biosimilar development. Launching a biosimilar product in the US can be more difficult because of the legal framework for biosimilar medicines has only just been developed. PTE Based on contributions by Keith Watson, Principal Consultant, Cecil Nick, Vice President, Biotechnology, and Bruce Babbitt, Principal Consultant, all at PAREXEL Consulting. The full version of this article can be read in the September issue of Pharmaceutical Technology Europe. 1 CONTENTS 9 TAKING ON REGULATORS 3 EGA INTERVIEW 10 LAUNCHING A BIOSIMILAR 7 SWOT ANALYSIS 13 BIOSIMILARS NOT COMPELLING

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - August 2010

Pharmaceutical Technology Europe - August 2010
Table of Contents
The Changing Landscape for Biosimilars
Interview with The European Generic Medicines Association
The Biosimilars Market Today and Tomorrow
A SWOT Analysis of the Biosimilars Market
Latest EU Guidelines Dissected
Taking On the Regulators: Is It Worth It?
Launching and Commercialising Biosimilars
Perception, Cost and the Impact on Biotech Innovation
Clinical and Cost Considerations of Developing a Biosimilar
True Biosimilars Do Not Offer a Compelling Business Case
What is Hindering the Uptake of Biosimilars

Pharmaceutical Technology Europe - August 2010