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Drawing on the strength of SAE Media Group's successful Generics, Supergenerics and Patent Strategies conference series, we are proud to present our inaugural Biosimilars & Biobetters: Aligning Business & Science for Success.
According to a recent report published by Biophoenix, in 2009 the biosimilar-susceptible segment of the biologic market was worth US$63 billion and by 2013 biosimilars could generate a total market of $5.6 billion. The key driver to biosimilar development is the expiry of patents across the older leading biologics and with many of these products beginning to come off patent between 2015 and 2016 this industry is set to grow at a significant pace.
Biosimilars have attracted a great deal of interest recently and are seen by some as the new generic frontier. It is widely thought that lower levels of competition will lead to higher margins in an industry notorious for its generally low margins on commodity generics. Payer pressure is expected to drive uptake, particularly in the German, UK and US markets.
The EU has led the way in bringing biosimilars safely to market in establishing an approval process for biosimilars, with many biosimilars already marketed. Recent developments have seen the United States establish a long awaited abbreviated approval pathway for biosimilar products and this will have major implications for both innovators and current biosimilar manufacturers.
Biosimilar manufacturers are also looking to strengthen their long term strategy, with many developing or acquiring technologies to produce improved biologics (or 'biobetters') to help compete against second generation innovator biologic drugs. Many believe that biobetters, with their improved characteristics are a more exciting and favourable proposition than biosimilars - will offer medical advantages along with a better price.
Hear experts in this field discuss the latest developments in legislation, regulation, technology and emerging commercial strategies to succeed in this highly competitive market.
Why not attend the associated pre-conference workshop as well?
Associated with the conference there will be a half-day interactive workshop on "Biosimilars: Understanding the Regulatory Processes and the Commercial Realities", taking place on 21st September. It will cover overview of the Biosimilars picture across the world and provide insight into the regulatory and commercial situation, now and in the future. This will be led by Peter Wittner, Senior Consultant at Interpharm Consultancy. To see more information about the workshop, please see the workshop page.
Keen to see the detailed programme? Click here.
Want to download the brochure? Click here.
Want to register your place? Click here.
Make a group booking - discounts apply

- Worldwide regulatory updates
- The developing U.S. follow-on biologics framework
- The challenges in biosimilar commercialisation
- Legal and IP developments
- Biosimilar and biobetter monoclonal antibodies
- Opportunities to drive a long term commercial strategy
- Effectively leveraging licensing opportunities
- Biosimilar quality aspects

Rahul Padhye
Head, Corporate Development
Reliance Life Sciences
Huub Schellekens
Professor, Department of Pharmaceutical Sciences & Innovation Studies
Utrecht University
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Conference programme
8:30 Registration & Coffee9:00 Chairman's Opening RemarksAlan Sheppard, Global Head Generics, Thought Leadership, IMS Health 9:10 Biosimilars - A global opportunity?Alan Sheppard, Global Head Generics, Thought Leadership, IMS Health
Current market penetration of biosimilars
Players and payers
Growth potential
9:50 Improving biosimilar delivery systems to compete with second-gen innovator productsKeith Powell, CEO, PolyTherics Ltd.
History of PEGylated biologics and comparing PEGylation to competing technologies
Choosing the best chemistry and the right-sized PEG
Process optimisation and benefits
Succeeding in a challenging market
10:30 Morning Coffee11:00 The developing biosimilars regulatory framework in the U.S.Dutch Chung, Associate, Wilson Sonsini Goodrich & Rosati
Review of U.S. statutory framework for handling biosimilar patent litigation
Impact on strategies for biosimilars product patenting
Strategies for biosimilars patent litigation and resolution in the U.S.
11:40 EU guidelines and biosimilar development strategiesPeter Gaskin, Principal Consultant, Aptuit
Latest guidelines and recommendations
Adopting the right development strategy
Ensuring guideline compliance
Illustrative case study
12:20 Networking Lunch13:30 EU legal developments and strategies for biosimilar medicines
New legislation/developments
Case law affecting biosimilars and bio-betters
Biosimilar patent disputes and best processes to handle them
Impact of special patent resolution procedures and potential patent strategies
Frank Landolt, VP Intellectual Property and Legal, Ablynx
Frank Landolt is a Dutch (1994) and European (1995) patent attorney and a licensing lawyer. After studying chemistry (M.Sc., 1990) and law (M.Sc., 1992) at Leiden University, he worked for almost ten years at the private practice firms of Polak and Charlouis (now EP&C) and Nederlandsch Octrooibureau in the Netherlands, where his clients included major pharmaceutical companies as well as biotech firms and research institutions. Prior to joining Ablynx as IP and legal counsel in 2004, he worked for 4 years as director of IP and legal counsel at Devgen N.V. Frank is a member of EPI, the Dutch Association of Patent Attorneys, LES and L'institut des Juristes d'Entreprise, and holds an M.Sc. in business law from the University of Antwerp (2006). Marc Martens, Senior Associate, Bird & Bird 14:10 Biosimilars as a new business opportunityAnjan Selz, CEO, FINox AG
Analyzing the business case through SWOT
Finding remedies to threats and weaknesses
Creating value for patients and shareholders
14:50 Afternoon Tea15:20 Clinical comparability and European biosimilar regulationsHuub Schellekens, Professor, Department of Pharmaceutical Sciences and Innovation Studies, Utrecht University
Quality differences between biosimilars and reference drug products
Equivalence margins, usefulness and discrepancies
Withdrawn biosimilars and important aspects
Should the biosimilar pathway be restricted only to biologics?
16:00 Leveraging biosimilars licensing opportunitiesRahul Padhye, Head, Corporate Development, Reliance Life Sciences
Opportunities in Biosimilars market
Commercialisation strategies/options for biosimilars
Licensing Deal - objectives, process, examples and key learnings
Reliance Life Sciences - overview, biosimilars business brief
16:40 Chairman’s Closing Remarks and Close of Day One8:30 Registration & Coffee9:00 Chairman's Opening RemarksDavid Szymkowski, Senior Director, Biotherapeutics, Xencor 9:10 Biosimilars in the clinicDavid Goldsmith, Consultant Nephrologist, St Thomas' Hospital
The changing physician outlook
Lingering concerns
The decision to substitute a biosimilar for a reference
Policies and economic pressures
9:50 EMA guidelines for biosimilar monoclonal antibodiesRobert Blakie, Director of Regulatory Affairs and General Manager (UK), Era Consulting (UK) Limited
Immunogenicity assessment annexe to existing guidelines
Level of similarity required - demonstrating further features
Clinical development and study design
mAb categorisation
Authorise as stand-alone or biosimilar and the evidence requirements
10:30 Morning Coffee11:00 Developing "biosuperior" monoclonal antibodiesDavid Szymkowski, Senior Director, Biotherapeutics, Xencor
Building biosuperiors based on leading mAbs & Fc fusions
A novel approach to develop fully human antibodies with enhanced in vivo activity
Commercial realities and strategies for innovators
Illustrative case studies and results
11:40 Biosimilar quality aspectsJean-Yves le Cotonnec, Managing Partner. Founder & CEO, TRISKEL Integrated Services S.A
Clinical relevance of differences
Demonstrating comparability
Bioassays to complement physicochemical methods
Variability of biosimilars, is this acceptable?
12:20 Networking Lunch13:50 Biosimilar CMC development - an innovator's point of viewMatthias Hoepfner, VP, Head GRA Global CMC & Change Management, Bayer Schering Pharma Reference characterisation
Importance of comparability - how similar is similar?
Factors introducing unpredictability 14:30 Interactive Panel DiscussionTopics including:
The market rationale for biosimilars - are they worth it?
Biosimilar or biobetter?
Developing regulatory and legislative perspectives
What about safety? Can biosimilars actually be registered on reduced clinical dataset
Sustainability and future industry directions
Rahul Padhye, Head, Corporate Development, Reliance Life Sciences Matthias Hoepfner, VP, Head GRA Global CMC & Change Management, Bayer Schering Pharma David Szymkowski, Senior Director, Biotherapeutics, Xencor 15:10 Immunogenicity of biosimilars and biobettersMatthew Baker, CEO & CSO, Antitope
Properties determining immunogenicity
Effects on efficacy, clearance and distribution
Unknown factors
Illustrative case studies in unwanted immunogenicity
Designing and generating biobetters to avoid immunogenicity
15:50 Chairman’s Closing Remarks16:00 Afternoon Tea16:30 Close of Conference
Workshops
Workshop Crowne Plaza - The City 21st September 2010 London, United Kingdom
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