Pharmaceutical Technology Europe - August 2010 - (Page 13)

True biosimilars do not offer a compelling business case The differences between biosimilars, biosuperiors and next-generation innovative drugs are not clearly defined. However, there is a consensus that biosimilars must replicate as closely as possible the innovator biologic. Since changes to biologics may result in unpredictable consequences, by definition, the biosimilar must be as good or as bad as the innovator drug in all respects. example, a biosuperior performance of cannot improve too the innovator. much upon the original On the other biologic or it becomes hand, biosuperiors a next-generation introduce more innovative drug, which clinical risk because has greater rewards new features have but also greater risks. been introduced into If the changes result the molecule. True David E. Szy mkowski in improved drug biosimilars do not Xencor properties with offer a compelling no change in function, it is a business case — the biosuperior drug; if changes result in risks of immunogenicity, of different an improvement in drug function, as pharmacokinetics, potency, stability, opposed to drug properties, it is an etc., more than negate the single innovative drug. advantage (cost) provided by such products. Without an existing defined Take the risk, reap path forward, and with the likely the rewards future path probably demanding Biosimilars have minimal (though clinical trials, there is little incentive to not absent) clinical risk relative to create a biosimilar. biosuperior approaches because the Biosuperiors, on the other hand, goal is to replicate exactly the clinical have much to offer and, in many ways, are even more attractive than next-generation innovative biologics. Biosuperiors have many of the benefits of biosimilars, but have a dramatically lower development risk compared with truly novel biologics. Since examples of all three classes of biologics are moving through clinical development now, these questions should all be answered with real-world data over the next few years. PTE “...the risks... more than negate the single advantage (cost) provided by [biosimilars]” Developers aiming to create a biosuperior can improve on the original to generate clinical and market advantages, but there is still a line that must not be crossed; for Based on a contribution by David E. Szymkowski, Senior Director of Biotherapeutics at Xencor. To read the full version of this article, go to 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