Pharmaceutical Technology Europe - August 2010 - (Page 10)

Launching and commercialising biosimilars When entering the biosimilars arena, there will be three main questions companies will be asking themselves: • Can highly comparable biological products be manufactured to exacting quality standards? Given the depth of knowledge involved in the creation of the originator product and advances in both analytical techniques and protein manufacturing this is highly complex, but it is achievable. • Can the requirements of the European regulators be satisfied? The guidance from the European Medicines Agency (EMA) is very clear, and several biosimilar products have already been approved. Significant expertise is required to complete the extensive clinical programmes, but, again, this is achievable. • Can products be commercialised once they reach the market? The main obstacle initially with commercialisation is the restrictions placed on pharmacy substitution of an originator drug with a biosimilar either for legal or Paul Greenla clinical reasons. nd Hospira Therefore, successful commercialisation will depend on winning the acceptance of clinicians, which will require investment in clinical detailing infrastructure. To make the situation more difficult, biosimilar manufacturers are also faced with originator companies who are desperately fighting the introduction of biosimilars. This is usually done through communication to key influencers and decision makers, with much effort directed at raising doubts over the safety of biosimilars. The future of the biosimilars market Biosimilars will continue to be developed and approved. However, the high cost of entry means that only those companies that are willing to absorb the costs and risks of development, registration and commercialisation will emerge as real competitors. In each therapeutic market I would expect to see only a handful of different biosimilar products — although several brands may be registered from each development programme. Eventually, the biosimilar market will evolve as a sizeable part of the pharmaceutical market that differs from both the originator and generic market. The commercialisation strategies for biosimilar manufacturers will probably develop as a hybrid of generic and originator approaches. In the early years, companies will use commercialisation tactics reminiscent of those for originator products including medical communication activities, clinical detailing to prescribers and product branding. These tactics will move eventually towards a more generic approach based on lowering the cost of sales as acceptance of quality, safety and efficacy increases. PTE Based on a contribution by Paul Greenland, Biosimilars Marketing Director for Europe, Middle East and Africa at Hospira. 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 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