Exclusive interviews released ahead of Biosimilars and Biobetters | 30th September - 1st October 2015, London, UK

This year's conference will address regulatory updates, pharmacovigilance of biosimilars, patent litigation, market access and global market developments. End Quote

(1888PressRelease) July 23, 2015 - SMi's 6th annual Biosimilars and Biobetters conference, taking place on 30th September - 1st October 2015 in London, will provide the ideal platform to engage in scientific discussions and debate the best practices and solutions to improve industry performance through technical case studies and practical advice from leading biosimilar and regulatory players including Harvest Moon Pharmaceuticals USA Inc, GfK, MHRA, Selecta Biosciences, Cinfa Biotech GmbH, Norwegian Medicines Agency and more.

Unique perspectives will be shared on:
• Evolving biosimilar regulatory landscape
• Market access and product commercialisation barriers
• Global marketing developments, including a focus on emerging market trends
• In-depth protein characterisation and analytical comparability to efficiently and effectively collect data

Industry specialists Richard DiCicco, Chairman from Harvest Moon Pharmaceuticals USA, Inc. and Jim Nelson, Senior Principal and Owner from Schwegman, Lundberg & Woessner, will be providing key insights through a case study driven presentations on developments in the US and the evolving biosimilars regulatory landscape.

Interview Snippets
When asked about innovation budgets, Richard DiCicco, Chairman from Harvest Moon Pharmaceuticals USA, Inc. said:
"Attendees will see that the data shows biosimilars will have only a 4% penetration rate by value from 2020 to 2030, therefore biosimilars have zero potential to wipe out innovation budgets. The delegates will take away detailed market forecasts for each biosimilar, year by year 2016-2030, for 50 biosimilars. That is 750 data points!"

When asked about Biosimilars and Biobetters developments in the US, Jim Nelson, Senior Principal and Owner from Schwegman, Lundberg & Woessner said:
"Demonstration of biosimilarity along with the US FDA requirements poses a significant technical challenge in the US. Litigation is omnipresent in this activity as it is in Hatch Waxman activity. So the main challenges in the US are successfully managing the U.S. FDA thicket and efficiently fighting the way through the patent thicket."

Featured Speakers Include:
• Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.
• Shahin Kauser, Senior Scientific Assessor, MHRA
• Chris Teale, Vice President Europe, GfK NOP Ltd
• Bracha Timan, Director, Israel Site Head, Global Bioassays & Technology, Global R&D, Teva
• Takashi Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
• Karsten Roth, Director Clinical Operations, Cinfa Biotech GmbH
• Alan Sheppard, Principal, Global Generics and Biosimilars, IMS Health
• Steinar Madsen, Medical Director, Norwegian Medicines Agency

To view the full speaker line-up, conference programme and to download the exclusive interviews, visit http://www.biosimilars-biobetters.co.uk/1888pressrelease

Plus, don't miss two half-day interactive conference workshops on:
A: Assessing the Regulatory Framework for Europe and the US - Developing Future Biologics
Led by: Lincoln Tsung, Daniel Kracov, Jennifer Sklenar, Partners, Arnold & Porter (UK) LLP
29th September 2015, 13.30 - 17.30

B: Biosimilars - Understanding the Regulatory Processes and the Commercial Realities
Led by: Peter Wittner, Senior Consultant, Interpharm Consultancy
2nd October 2015, 08.30 - 12.30

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Exclusive interviews released ahead of Biosimilars and Biobetters | 30th September - 1st October 2015, London, UK by Smi Group