1. 7th Annual
Biosimilars
Optimising commercial strategies to develop Biosimilars and Biobetters
5th - 7th October 2010, BSG Conference Centre, London, UK BOOK NOW!
Key Speakers
Dr Gillian Cannon, Executive Director - Commercial Operations, Merck Bioventures
Dr Anne Cook, Biologicals Quality Assessor, Biologicals and Biotechnology Unit, MHRA
Mohamed Oubihi, Senior Manager, International Regulatory Affairs, Biogen Idec
Jo Pisani, Partner Strategy, PricewaterhouseCoopers LLP
Mateja Urlep, Founder & CEO, Tikhe Pharma, Former Global Head of Marketing and Medical, Sandoz
Dr Fernando de Mora, Chairman, Dept of Pharmacology, Universitat Autònoma de Barcelona & Partner, Salupharma
Robin Thorpe, Head - Biotherapeutics Group, National Institute for Biological Standards and Control
Dr David Goldsmith, Consultant Nephrologist, Guy’s Hospital and St Thomas’ NHS Foundation Hospital, UK
Michael Dilger, Senior Director, Simon-Kucher & Partners
Pre conference workshop Tuesday 5th October, 2010
Patent issues in the development of biosimilar medicines
Led by: Dr Duncan Curley, Director, Innovate Legal
Associate Sponsors
Driving the Industry Forward | www.futurepharmaus.com
Organised By
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilars

2. Conference Introduction
7th Annual Biosimilars
5th - 7th October 2010, London UK
Dear Colleague, Associate Sponsors
Biosimilars, biobetters and follow-on biologics are the new wave of growth for the PharmaNet Devel PharmaNet Development Group, a global,
pharmaceutical industry. According to the GIA report, the market for biosimilars in drug development services company, provides expertise to the
the US, Europe, and Japan is projected to exceed US$2 billion by 2015. As numerous pharmaceutical, biotechnology, generic drug, and medical device industries. PharmaNet
countries including the United Status and EU collaborate, there exists a huge companies offer clinical development solutions including consulting services, Phase I clinical
challenge in developing biosimilars across regulated and unregulated markets. studies, bioequivalency and pharmacodynamic studies, bioanalytical analyses, and Phase II,
With the newly introduced US health reform bill, the branded drugs would be given a III, and IV clinical development programs. With more than 2,300 professionals in 40 offices
12-year exclusivity period before generics may be developed. The new legislation also around the world, PharmaNet is a recognized leader in outsourced clinical development.
allows FDA to approve generic versions of biological drugs. It is vital to understand For further information please visit: www.pharmanet.com
what will the future hold for the global biosimilars sector?
PAREXEL Consulting provides integrated product development services,
Visiongain’s 7th Annual Biosimilars Conference will discuss strategies to understand
helping biopharmaceutical and medical device companies shorten time to
the complexity of regulatory framework, overcome barriers and gain market access market and maintain product viability for the long-term. Through our unique fusion of scientific,
within the global landscape. Our distinguished panel of speakers and interactive regulatory, and business expertise, we help clients manage risk and maximize product value at
sessions will provide key solutions to identify growth areas and achieve commercial every milestone and phase of development worldwide.As leaders in biosimilars development,
success for biosimilars across diverse environments. Learn, maximise your knowledge we played an integral role in bringing the first biosimilars to the EU market, and are actively
and network with diverse industry leaders at our global forum. working with clients seeking FDA biosimilar approval. Download our latest biosimilars white
papers on The Dawn of US Biosimilars and Biosimilar mAbs at www.parexel.com.
Key topics of discussion include: For further information please visit: www.parexel.com
• Gaining insights of the competitive landscape in biosimilars: US, EU and Media Partners:
emerging markets PharmiWeb.com is the leading industry-sponsored portal for the
• Evaluating biobetters and differentiated biosimilars as practical alternatives to pharmaceutical sector. Supported by most of the leading pharmaceutical
biosimilars for regulated markets corporations, PharmiWeb.com provides dynamic real-time news, features, events listings
and international jobs to industry professionals across Europe and the US.
• Implementing successful commercial models for biobetters and follow-on
biological medicines For further information please email: corporate@pharmiweb.com
• Reviewing the global pricing and reimbursement models in the biosimilars and BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD.
generics market It is based and located in Warsaw, Poland. Biotechnology World was
founded in 2007 to provide the world’s biotech and pharma information and market to
• Learning the impact on biosimilars product patenting make it universally accessible and useful for scientific and business processes. Its first step
• Leveraging licensing opportunities for biosimilars to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will
• Validation of biomarkers and comparative immunogenicity as surrogate endpoints allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers
companies completed internet public relations, publication and marketing solutions. One of
• Exploring technologies for producing improved biologics: Drug delivery, half-life the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector
extension, cell production, and glycoengineering methods in Europe to global biotechnology, pharmaceutical and life science activities.
I look forward to meeting you at the conference For further information please visit www.biotechnology-europe.com
Best regards
Future Pharmaceuticals has forged powerful relationships with key industry
Driving the Industry Forward | www.futurepharmaus.com
leaders to provide a platform for successful brand recognition, and for
senior decision-makers to have the means to procure and plan implementation strategies based
on the topics covered. Positioned to be an authoritative resource within top pharma companies
Maninder Paul as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a
Conference Producer deep penetration into a highly targeted and responsive audience, bridging the gap between the
industries’ top issues and the solutions top-tier vendors can provide.
For further information please visit: www.futurepharmaus.com
InPharm is the online platform for exclusive pharmaceutical
Who should attend? news, comment, contracts, services, jobs and events and is
Members of Board, Vice President, Directors, Heads and Senior home to InPharmjobs.com, Pharmafile and Pharmafocus.
Managers involved in: For further information please visit: www.In-Pharm.com
• Follow-on Biologics/Follow-on Proteins/Biosimilars Pharma Connections Worldwide® is the leading professional business
• Biologics/Biotechnology/ Biogenerics networking website focused in the Pharmaceutical, Biotechnology and Life
• Biopharmaceuticals/ Biotherapeutics Sciences research industry. Our goal is to provide a conduit for delivery of premiere content
• Clinical Immunology coupled with the right clientele in order to facilitate business development opportunities
• Process Control and Analytical Technologies among industry professionals responsible for making key decisions in a global marketplace.
• Quality Affairs/ Quality Control For further information please visit www.pharmaconnections.com
• New Product Development
• Process Science
• Analytical Characterisation
• Research & Development Sponsorship and exhibition opportunities:
• Quality Assurance
This event offers a unique opportunity to meet and do business with some of the
• Scientific Affairs key players in the pharmaceutical and biotech industries. If you have a service or
• Commercial Affairs product to promote, you can do so at this event by:
• Legal Affairs • Hosting a networking drinks reception
• Intellectual Property
• Taking an exhibition space at the conference
• Health Economics
• Pricing and Reimbursement • Advertising in the delegate documentation pack
• Regulatory Compliance • Providing branded bags, pens, gifts, etc.
• Pharmacovigilance If you would like more information on the range of sponsorship or exhibition possibilities
• Business Development for visiongain's 7th Annual Biosimilars Conference, please contact us:
• Marketing & Sales Ronald Magali, +44 (0)20 7549 9934
- Branded and Generic Pharmaceuticals & Biotechnology Companies ronald.magali@visiongainglobal.com
- CROs/CMOs James Hopkins, +44 (0)20 7549 9974
- Drug Regulators, Academic & Government Bodies james.hopkins@visiongain.com

3. Pre-Conference Interactive Workshop
7th Annual Biosimilars
Tuesday 5th October 2010, London UK
Patent issues in the development
of biosimilar medicines
Led by: Dr Duncan Curley Timings: 09:30 - 10:00 Coffee & Registration
Director 10:00 - 15:00 Workshop
Innovate Legal
Timing includes lunch and refreshment breaks
About the workshop: Workshop agenda:
Biosimilar medicines are already a commercial reality in the European
09:30 Registration and Refreshments
Union. The U.S. Healthcare Reform Bill, with its defined pathway for
the regulatory approval of follow-on biologics, should open up the U.S.
10:00 PART 1 – A EUROPEAN PERSPECTIVE
market in the coming years. However, the next wave of biosimilars
faces other difficulties in reaching the market, both in the EU and in the
10:10 Patent issues in the development of biosimilars – an
USA, because many valuable second generation biological products are
introduction
better protected by originator patent estates. The aim of this workshop
is to examine and discuss the patent issues that may be confronted in
10:30 Insulin analogues
developing biosimilar products for these markets. The discussion will be • Commercial overview
framed by reference to specific products. There will also be an analysis • Rapid and long-acting insulin analogues
of the patent dispute procedure in the new U.S. legislation.
11:30 Morning Refreshments
About the workshop leader: 11:45 Pegylation
Dr Duncan Curley qualified as a • PEG-interferon
solicitor in 1995. He became a • PEG-filgrastim
partner in the intellectual property (IP) department
of an international law firm in 2003 and he founded the boutique 12:30 Monoclonal antibodies – the EU guidelines
London-based IP law practice, Innovate Legal, in 2007. Duncan is
a life sciences specialist and he acts for a number of multinational 13:00 Lunch
pharmaceutical companies on freedom to operate, patent clearance
and litigation issues. He has worked on many high profile cases, PART 2 – A U.S. PERSPECTIVE
including Lenzing v Courtaulds (fibre technology), Bespak v 3M
(metered dose inhalers for asthma), Pliva v Eli Lilly (gemcitabine) 14:00 The U.S. approval pathway for Biosimilars – An update
and two of the major UK cases on antitrust ‘Eurodefences’ to IP • Terminology: “highly similar” and “interchangeable”
claims (Sandvik v Pfiffner, patents and Sportswear v Stonestyle, • Data exclusivity
trade marks). He is the author of numerous published articles on IP • The patent dispute procedure
issues, the textbook “Intellectual Property Licences and Technology
Transfer” (on the European Technology Transfer Block Exemption) and 14:45 Discussions and questions
“Extending Rewards for Innovative Drug Development”, a Report on
Supplementary Protection Certificates, published in December 2007 by 15:00 Close
the Intellectual Property Institute.

4. Day 1
7th Annual Biosimilars
Wednesday 6th October 2010, London UK
09:00 Registration and refreshments 13:40 Biosimilars: Between innovator biomedicines and
classcal generics
09:30 Opening address from the chair • The rationale behind the EMA regulation on biosimilars
Dr Fernando de Mora • Answering payers, patients and prescribers concerns about biosimilars
Chairman, Dept of Pharmacology,
Universitat Autònoma de Barcelona • Biosimilar vs. the generic market
Partner, Salupharma  • Need for a specific strategic approach to the biosimilar market
Dr Fernando de Mora
09:40 Understanding the competitive landscape Chairman, Dept of Pharmacology,
in biosimilars Universitat Autònoma de Barcelona
Partner, Salupharma
• Exploring the biosimilars opportunity
• Exploring obstacles to entry: Strategic, pricing, sales & marketing 14:20 Comparability evaluation of biological products
• Assessing the major markets for biosimilars: US, EU and emerging markets • Evaluation: Biochemical characterisation, non-clinical and
• Identifying current and potential players and business models clinical characterisation
• Elements to successful biosimilar comparability
Jo Pisani
Partner • Process & product comparability
PricewaterhouseCoopers
Dr Anne Cook
Biologicals Quality Assessor, Biologicals and Biotechnology Unit
10:20 Overview of Japanese regulatory framework on MHRA
biosimilars: Trends, opportunities and challenges
• Introduction of Japanese regulatory environment and biosimilars market 15:00 Afternoon refreshments
• PMDA’s new guidelines on follow-on biologics
• Opportunities and challenges 15:20 Comparability, biosimilars, “interchangeable
biosimilars,” and current US legislation
Mohamed Oubihi
Senior Manager, International Regulatory Affairs • Comparability as a physical-chemical exercise: Limitations
Biogen Idec and open questions
• Biosimilars and the FD&C Act: Biosimilars and the US Public
11:00 Morning refreshments Health Service Act
• Biosimilars and interchangeability
11:20 Impact of healthcare reform on biosimilars in global • Biosimilars and “proper names”
biosimilars development
William Egan, Ph.D
• Anti-trust aspects (comparing FTC latest reactions as well as its Vice President
June 2009 report) PharmaNet
 • Patent aspects and the creation of new “Orange book-like system”
 • Regulations promulgated pursuant thereto 15.40 Unwanted immunogenicity of biologicals
and biosimilars
Liz Fuller
Director, Life Sciences Regulatory (US qualified) • The problems of unwanted immunogenicity for biologicals
Wragge & Co
• Assessing unwanted immunogenicity
• Guidance available, including regulatory guidance
12:00 Biosimilar erythropoietin: Uptake in Europe
• Specific issues with immunogenicity of biosimilars
• Rationale for biosimilar epoetins
• Epoetin market factors Robin Thorpe
Head - Biotherapeutics Group
• EMEA regulatory environment National Institute for Biological Standards and Control
• Clinical considerations
Dr David Goldsmith 16:20 Closing remarks from the chair
Consultant Nephrologist
Guy’s Hospital and St Thomas’ NHS
Foundation Hospital
16.30 Networking drinks
12:40 Networking lunch Take your discussions further and build new
relationships in a relaxed and informal setting
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010

5. Day 2
7th Annual Biosimilars
Thursday 7th October 2010, London UK
09:00 Registration and refreshments 13:40 Believing in biobetters: Half-life and antigenicity
• Global market overview for protein drugs
• Future of biosimilars/biobetters
09:30 Opening address from the chair
• Extending the half-life/duration of action of biologics
• Efficacy and safety of PEGylated products
09:40 Developing a long-term commercial strategy Keith Powell
for biosimilars CEO
Polytherics
• Challenges in commercialisation of biosimilars
• Understanding the evolving US and EU market environment
• Meeting the standards defined by the EMEA and US 14:20 Presentation TBC
Dr Gillian Cannon Representative
Executive Director - Commercial Operations Parexel
Merck Bioventures
14:40 Afternoon refreshments
10:20 Revolutionising biosimilar development in
the EU market
• Are current regulations adequate?
 • Navigating the complexity: Review of the EU guidelines
15:00 The regulatory approaches to chemicals and
• Indentifying the risks and benefits for successful development
biologicals - Is it time that the “Process is the
Mateja Urlep
Product” finally died?’’
Founder & CEO, Tikhe Pharma
PANEL DISCUSSION
Former Global Head of Marketing and Medical, Sandoz Panel members will be drawn from the speakers who take part on day one
or day two. If you would like to submit a question to the panel, please
email it to: maninder.paul@visiongainglobal.com
11:00 Morning refreshments Panelists:
Jeff Edwards
Development Director
11:20 Overcoming CMC challenges for successful Polytherics
biosimilars development
• CMC: Effective process development & biologics manufacturing
• Establish knowledge-based process strategy early using QbD & PAT
• Development capabilities and infrastructure requirements 15:40 Emerging markets: A spotlight on Asia
• Understanding the dynamics of the Asian markets
• Benefits and risks of outsourcing the development of biosimilars
12:00 Global P&R models for the biosimilars and
generics market • Explore partnership opportunities
• Health economic challenges of R&D, registration, P&R of
biopharmaceuticals and biosimilars
16:20 Chair’s closing remarks
• Identifying inherent differences in safety, effectiveness and costs
• Adopting innovative mechanisms such as risk-sharing arrangements
Michael Dilger 16:30 End of Conference
Senior Director
Simon-Kucher & Partners
12:40 Networking lunch

6. Registration Form
7th Annual Biosimilars
5th - 7th October 2010, London UK
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For multiple bookings Pentonville Road
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