Pharmaceutical Technology Europe - August 2010 - (Page 9)

Taking on the regulators: is it worth it? The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe. In general, however, regulated markets demand that the applicant conduct a series of studies designed to prove clinical equivalence of the copy to the original, as well several years. However, some example, Amgen stated see this as an excessively in its Q1 earnings call cautious approach. for 2010 that biosimilar Writing in a recent versions of Filgrastim Nature Biotechnology had only taken a 3% Commentary article, market share from its Professor Huub Schellekens branded product. and Dr Ellen Moors of However, with some Peter Witter Independent Utrecht University in The leading biological Consultant Netherlands suggested: products totalling sales “Clinical trials required by European of approximately $5 billion in 2009 regulators to compare biosimilar in Europe and the US alone, taking products with corresponding biologic even a small share of the sales would brands are surplus to requirements benefit healthcare payers and, and may even be a barrier for the naturally, biosimilar manufacturers. development of biosimilars of more complicated biologics”. Key factors to consider At the opposite end of the scale The key factors to consider when are less-developed markets where entering the biosimilars market regulators may ask for virtually no depend on whether a company data before allowing a biosimilar is planning to enter a regulated product to reach the market. or unregulated market because To date, biosimilars have had only the operating parameters limited success in taking business away vary considerably. The issue from the original biotech products. For of interchangeability is almost irrelevant in unregulated markets where products are selected on the basis of price. In this situation, low manufacturing costs and the ability to respond quickly to new orders are paramount. By contrast, in regulated markets, the key factors are a company’s ability to reach decision makers, and promote and detail their biosimilar products. In addition, companies will need to have deep pockets to fund both the expensive promotional efforts and the extensive pharmacovigilance programme. PTE Based on a contribution by Peter Wittner, an independent consultant. To read the full version of this article, go to “...companies will need to have deep pockets to fund both the expensive promotional efforts and the extensive pharmacovigilance programme.” as lack of immunogenicity. These requirements make the development phase much more expensive and the regulatory phase far more time consuming compared with generics. European authorities have had clear guidelines for biosimilars in place for 1 CONTENTS 9 TAKING ON REGULATORS 3 EGA INTERVIEW 10 LAUNCHING A BIOSIMILAR 6 THE BIOSIMILARS MARKET 11 IMPACT ON INNOVATION 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