Pharmaceutical Technology Europe - August 2010 - (Page 14)

What is hindering the uptake of biosimilars? The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages. Unlike with classical generics, manufacturers must submit animal data and data on efficacy in patients in order to obtain marketing authorisation for a biosimilar — the exact requirements depend on the the European Medicines Slow uptake Agency (EMA) have not Although the key set any specifications selling point of a concerning the differences biosimilar is its low that are acceptable price, this may not be between the biosimilar deemed sufficiently and the original product. lower than the Differences will always originator to stimulate Huub Schell ekens Utrecht Univ be found, for instance its use. Additionally, ersity in the glycosylation in general, clinicians between two epoetin products, prefer not to switch patients from but if the clinical data show that one biologic to another. This is these differences are not clinically reinforced by statements by the important, the EMA will accept them. EMA, which state that a biosimilar In practice biosimilar manufacturers authorisation does not imply that have analysed the original product the product is exchangeable with the for a number of years to get data original, as is the case with generics. on the batch-to-batch variation and In addition there are concerns about their specifications are set based on the long-term safety of biosimilars. the quality of the original. In Utrecht Because they have only recently University we are currently analysing been introduced; clinicians want to the quality of biosimilar epoetins wait for a couple of years until the and we find these comparable and safety is established. As such, all sometimes even higher in quality biosimilar companies are required by than the originals. the EMA to study long-term safety post-marketing. Further, to make the biosimilar treatment traceable, substitution without the consent of the treating physician is discouraged and even made illegal in some European countries. PTE Although the key selling point of a biosimilar is its low price, this may not be deemed sufficiently lower than the originator to stimulate its use. product. Another important part of the biosimilar submission process is the similarity exercise, where the biosimilar must prove to be sufficiently similar to the original product in terms of quality, safety and efficacy. Regulations from Based on a contribution by Huub Schellekens, Professor in the Department of Pharmaceutical Sciences and Innovation Studies at Utrecht University (The Netherlands). To read the full version of this article, go to www.pharmtech.com/schellekens www.uu.nl 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 http://www.pharmtech.com/schellekens http://www.uu.nl

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