2nd - 4th March 2010, Boston, USA

Organised By

Revolutionizing biosimilars market - debates, challenges and innovations

To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilarsusa

Tina S. Morris, Vice President, Biologics and Biotechnology, United States Pharmacopeial Convention

Yining Zhao, Associate Research Fellow, Strategy Management Group, Pfi zer

Dr. David L. Gollaher, President and Chief Executive Offi cer, California Healthcare Institute

Les Jordan, CTO, Life Sciences Industry Unit, Microsoft

Terry Hisey, Vice Chairman, U.S. Life Sciences Leader, Deloitte LLP

James Harris, CEO, Healthcare Economics LLC

Clifford S. Mintz, Founder, BioInsights

Mateja Urlep, Director, TikhePharma

Dr Duu-Gong Wu, Executive Director, Pharmanet

Brian J. Del Buono, Director, Sterne, Kessler, Goldstein & Fox

Dr. Fethi Trabelsi, Director, Scientifi c & Regulatory Affairs, Anapharm

Roger Lias, President, Eden Biodesign

Senior Representative, Paraxel Consulting

Key Speakers

BOOK NOW!

6th Annual

Biosimilars Conference

Media Partners

Driving the Industry Forward | www.futurepharmaus.com

Pre conference Workshop, Tuesday 2nd March 2010

Creating confi dence in a new wave of biologics therapy - Overcoming barriers to entryled by: Gil Bashe, Executive Vice President, Health Practice, Makovsky + Company

Conference Introduction6th Annual Biosimilars Conference

2nd – 4th March 2010, Boston, USA

Dear Colleague, Biologics constitutes a major share of expenditure in the USA and globally. It is one of the

fastest growing sectors of the pharmaceutical industry which corresponds to over 15% of the total pharmaceutical market.

There is a large and potentially lucrative demand for lower cost biological drugs worldwide.With favourable regulatory developments, the biosimilar sector should pick up signifi cantly, however, forming an important developing pharma market.

Visiongain’s 6th Annual Biosimilars Conference will feature keynote addresses, presentations, case studies and interactive discussions from regulatory issues to manufacturing process, clinical assessment, commercialization and pricing.

This three day event is an ideal forum for experts from the industry and academy sector together to discuss and share their experience and best practices.

Why Attend? • Discover the key strategies for process development/manufacturing of biosimilars

• Discuss the key regulatory and scientifi c issues of biosimilars and follow-on biologics

• Examine commercialisation of biosimilars

• Understand the development and marketing of biosimilars

• Assessing impact of IT driven patient adherence methodologies on biologics and biosimilars

• Learn how to develop and create strategic outsourcing strategies for biosimilars

• Network and discuss ideas with the leaders in the fi eld

I look forward to meeting you at the conference Best regards

Pranita Nangia Conference Producer

Who should attend?Branded Biotechnology, Pharmaceuticals & Generic Pharmaceutical Companies, Drug Regulators, Healthcare Agencies, Government Departments, Contract Research/Bio manufacturing, Organisations, Regulatory Affairs, PharmacovigilanceVPs, Directors, Heads, Managers of:

• Follow on Biologics/Follow on Proteins/Biosimilars• Biologics/Biotechnology/ Biogenerics• Legal Affairs• Intellectual Property• Health Economics• Pricing and Reimbursement• Biopharmaceuticals/ Biotherapeutics• Clinical Immunology• Principal Scientist• Payers• Chief Scientifi c Offi cer• Process Control and Analytical Technologies• Analytical Characterisation• Regulatory Compliance• Pharmacovigilance• Drug Safety & Risk Management• Quality Affairs/ Quality Control• New Product Development• Process Science• Portfolio Management• Research & Development• Business Development• Business Operations• Scientifi c Affairs• Commercial Affairs• Marketing

Sponsorship and exhibition opportunities:This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by: • Hosting a networking drinks reception • Taking an exhibition space at the conference • Advertising in the delegate documentation pack • Providing branded bags, pens, gifts, etc.If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 6th Annual Biosimilars Conference, please contact us:

Sandra Clout +44 (0)20 7549 9969 sandra.clout@visiongainglobal.com

Media Partners:PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading

pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US.

For further information please email: corporate@pharmiweb.comBIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. 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 make it universally accessible and useful for scientifi c and business processes. Its fi rst step to fulfi lling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities.

For further information please visit www.biotechnology-europe.comFuture Pharmaceuticals has forged powerful relationships with key industry 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 as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a 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.comInPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to

InPharmjobs.com, Pharmafi le and Pharmafocus.

For further information please visit: www.In-Pharm.com‘Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical,

Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. ‘For further information please visit: www.pharmaconnections.com

“The US biosimilar market, generating $0.06bn sales in 2008, will achieve signifi cant revenues only after expected implementation of a biosimilar regulatory pathway in 2013, visiongain predicts. If this occurs, the US biosimilar market will increase to annual revenues of $1.95bn in 2014” (Source: Visiongain Report ‘Biosimilars and Follow-on Biologics 2009-2024’ Published: April 2009)

Driving the Industry Forward | www.futurepharmaus.com

Biosimilars and Follow-On Biologics Report: The Global Outlook 2009-2024

A visiongain report

About visiongain: Visiongain is a specialist business information company focused on providing cutting edge products and services across the Pharmaceutical/Biotech, Telecommunications, Defence and Finance sectors, which include reports, conferences, online daily news and offl ine news analysis and bespoke consultancy. With a commitment to innovation and excellence, visiongain offers fl exible solutions to meet our clients’ business intelligence needs, providing the right information at the right time to facilitate the commercial decision-making process. Our pharmaceutical products include Pharma Business Daily, the leading daily email newsletter for the pharmaceutical, biotech and healthcare industries, and a range of independent, high-quality, in-depth reports covering focused and topical areas of concern. Our pharmaceutical conferences address the hottest commercial, regulatory and technical topics and provide an ideal forum for debate and networking for pharmaceutical professionals from around the world.

For further information, please visit: www.visiongain.com

Pre-Conference Interactive Workshop6th Annual Biosimilars Conference

Tuesday 2nd March 2010, Boston, USA

Creating confidence in a new wave of biologics therapy - Overcoming barriers to entry

About: Makovsky + Co

Founded in 1979, Makovsky + Company is today one of the nation’s leading independent global public relations consultancies. The firm attributes its success to its original vision: that the Power of Specialized ThinkingTM is the best way to build reputation, sales and fair valuation for a client. Celebrating its 30th year in 2009, Makovsky has received numerous industry accolades including; the American Business Awards 2009 PR Agency of the Year and Holmes Report 2009 Multispecialist Agency of the Year. Based in New York City, the firm has agency partners in more than 26 countries and in 35 U.S. cities through IPREX, the third largest worldwide public relations agency partnership, of which Makovsky is a founder. For further information, please visit: www.makovsky.com

Gil Bashe, Executive Vice President, Makovsky + Co

Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, sanofi-aventis

Kristie Kuhl, JD, Senior Vice President, Makovsky + Company

Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy

Timings: 09:30 - 10:00 Coffee & Registration 10:00 - 15:00 Workshop

Timing includes lunch and refreshment breaks

Led by:

About your workshop leaders:

Gil Bashe, Executive Vice President, Makovsky + Co Workshop Leader

Mr. Bashe is counselor to pharmaceutical, biotechnology, medical-device manufacturers and patient advocacy groups. He has advised clients on follow-on-biologic (FOB) policies and reimbursement, first in Europe and now in the United States. Mr. Bashe is a limited partner with GTCR Golder Rauner, one of the nation’s leading private-equity firms and was CEO of CommonHealth, a WPP Group company, having served as at sister-company Hill and Knowlton as Worldwide Health Practice director overseeing policy, provider and product communications.

Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, sanofi-aventis

Dr. Harvey leads the sanofi-aventis Corporate Regulatory Affairs (CRA) office in Bethesda, Maryland and interacts with the Food and Drug Administration (FDA), C-Path Institute and key industry representatives on behalf of sanofi-aventis. He represents sanofi on PhRMA, Regulatory Affairs Coordination Committee, and BIO’s Regulatory Affairs Committee. Prior to joining sanofi, Dr. Harvey worked at the FDA in CDRH, CBER and CDER centers for more than 11 years and worked on health issues in the U.S. Senate. Dr. Harvey completed his Ph.D. in biochemistry and his M.D. degree at the University of Connecticut.

Kristie Kuhl, JD, Senior Vice President, Makovsky + Company

Kristie Kuhl provides counsel on issues that impact biotechnology, specialty pharma, dietary supplements and medical devices. Her legal and communication skills provide keen insight in bringing together communities with diverse interests especially important in the FOB arena. She has provided counsel on the issues surrounding biosimilar approvals in Europe including communicating the differences between biosimilars and generic drugs.

Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy

Dr. Francis Palumbo is both a lawyer and registered pharmacist and approaches biosimilars with a unique perspective. He has a strong interest in pharmacy and food and drug law, pharmacoeconomics, pharmacoepidemiology and health services research. As an adjunct professor at the Maryland School of Law, he teaches a course in food and drug law, including content on foods, dietary supplements, drugs and other products regulated by the FDA and its sister agencies. Dr. Palumbo received his B.S. in Pharmacy from the Medical University of South Carolina, M.S. and Ph.D. in Health Care Administration from the University of Mississippi and J.D. from the University of Baltimore Law Center.

Agenda:Legislative pathways for biosimilar regulatory approval may provide significant implementation confusion. The wrong path to biosimilar approval may jeopardize ability to develop future advancements and place obstacles in the path to reducing healthcare costs. The debate on whether legislation is pro-innovator or biogenerics entrepreneur may overshadow addressing key concerns for future success. This workshop will summarize the key concerns and enable participants to tackle these issues. Discussions include:

• How much authority will FDA have to make case-by-case approval decisions?

• What should the clinical data requirements be for approval, immunogenicity and subsequent interchangeability?

• Class and product-specific naming

• How should market exclusivity address ever greening?

• How does patent law affect FOBs entry into the market?

• What should the nomenclature system be to reduce confusion and promote patient safety?

Day 16th Annual Biosimilars Conference

Wednesday 3rd March 2010, Boston, USA

09:30 Registration and refreshments

10:00 Opening address from the chair

James Harris CEO Healthcare Economics LLC

10:10 Opportunities and challenges for biosimilars in the global market

• Assessing the promise and potential for biosimilars

• Latest progress in biosimilars development

• Regulatory update on bioequivalence, interchangeability and substitution for biosimilars

• Provider perspectives and acceptance of biosimilars

• Payer perspectives and formulary acceptance

• Examining the viability of biosimilars & ROI considerations

James Harris CEO Healthcare Economics LLC

10:50 Commercializing biosimilars: Will they really be able to compete?

• Size and location of markets

• Manufacturing and distribution challenges

• Interchangability and substitution issues

• Branding and pricing concerns

• Market penetration and physician uptake

Clifford S. Mintz Founder BioInsights

11:30 Morning refreshments

11:50 Demystifying the market aspects/implications of follow on biologics

• Market positioning and attractiveness

• Strategies

• Commercial operations

R.T. (Terry) Hisey Vice Chairman and U.S. Life Sciences Leader Deloitte LLP

12:30 Presentation to be announced

Dr. David L. Gollaher President and Chief Executive Officer California Healthcare Institute (CHI)

13:10 Networking lunch

14:30 The impact of a patient centric viewpoint on biosimilars

• Review of emerging PHR and patient centric healthcare information technology (HIT) and how it applies to biosimilars

• Includes a discussion of the effect of IT driven patient adherence methodologies on biologics and biosimilars

Les Jordan CTO, Life Sciences Industry Unit Microsoft

15:10 Strategies for process development/manufacturing of biosimilars (for global markets)

• The biosimilar CMC section - what does it look like?

• Where (if anywhere) can time be saved when developing a biosimilar production process?

• Derivation of cell lines and materials

• The importance of analytics and comparability protocols

• Early mistakes can be expensive - what to be aware of

Dr. Roger Lias President Eden Biodesign

15:50 Afternoon refreshments

16:10 Presentation to be announced

Senior Representative Parexel

16:50 Acceptance criteria for immunogenicity of Biosimilars

• Assessing the risk of strategies of immunogenicity

• Evaluating the potential of immunogenetic response

17:30 Closing remarks from the chair

17:35 Networking drinks

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, 2009

Day 26th Annual Biosimilars Conference

Thursday 4th March 2010, Boston, USA

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Role of USP standards in the quality assessment of biological medicines

• Role of the official compendial and standard-setting process

• Value of public standards and monographs

• Quality assessment of biological medicines

• Analytical challenges and future developments

Tina S. Morris Vice President, Biologics and Biotechnology United States Pharmacopeial Convention

10:50 An overview on regulatory and scientific issues of biosimiars and follow-on biologics

• Updates on regulatory and, scientific issues related to biosimilars and follow-on biologics

• Discussions on technical challenges for the approval of biosimilars/follow-on biologics

• Requirements of CMC, pre-clinical and clinical studies using examples of approved products in both US and Europe

Dr. Duu-Gong Wu Executive Director, Consulting Division PharmaNet

11:30 Morning refreshments

11:50 Legislative and regulatory developments impacting the biologics and biosimilars marketplace

• Update on progress of biosimilars legislation through the U.S. House and Senate

• Analysis of the provisions of the competing U.S. bills

• Comparison of the proposed biosimilars legislation to small molecule regulation under Hatch-Waxman

• Views of affected constituencies (biopharma companies, generics companies, health care providers, patients)

• Comparison of the proposed US regulatory scheme to those in other parts of the world (especially Europe and Japan)

Brian J. Del Buono Director Sterne, Kessler, Goldstein & Fox

12:30 Trends and technical challenges for the development of biosimilars in China

• Understanding the current competitive landscaping of China’s biosimilars market

• Addressing the critical issues and gaps of China’s biologics R&D and manufacturing capabilities

• Discussing the trends and opportunities of the biosimilars/biobetters in China

Yining Zhao Associate Research Fellow, Strategy Management Group Pfizer

James Leung Founder James Leung Consulting

13:10 Networking lunch

14:30 Pharmacovigilance and risk management plans

• Evaluating key challenges

• Thorough risk-benefit analysis

• Need for a robust pharmacovigilance plan

15:10 Biosimilars - Succeeding in the market of the future

• From dream to reality

• The global biosimilars market today

• Lessons learned so far

• Evolving business models

• Delivering against the promise?

Mateja Urlep Founder, Tikhe Pharma Former Global Head of Marketing and Medical, Sandoz

15:50 Afternoon refreshments

16:10 Clinical Phase 1 PK/PD trials for biosimilar/follow-on products

• The clinical comparability exercise

• PK/PD studies for early efficacy and safety assessment

• Study design challenges with some particular specific biosimilars

Dr. Fethi Trabelsi Director, Scientific & Regulatory Affairs Anapharm

16:50 Presentation to be announced

17:30 Chair’s closing remarks

17:40 End of Conference

* Invited

How to bookEmail: conferences@visiongainglobal.com Web: http://www.visiongain.com/biosimilarsusa

UK Offi ce:Tel: +44(0) 20 7336 6100Fax: +44(0) 20 7549 9932 Visiongain LtdBSG House226-236 City Road LondonEC1V 2QYUK

General informationVenue: TBA

Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the right to charge interest on unpaid invoices.

Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences and executive briefi ngs. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organisation and are not transferable between countries.

Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the customer by credit card prior to the changes being made.

Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefi ng content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or expenses, which may be incurred by the customer as a consequence of the event being postponed or cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses.

Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Protection Act 1988. Your personal information contained in this form may be used to update you on visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you wish for your details to be amended, suppressed or not passed on to any external third party, please send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from visiongain Ltd during the transitional period, whilst the changes are coming into effect.

Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain).

VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT.

How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you.

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Registration Form6th Annual Biosimilars Conference

2nd – 4th March 2010, Boston, USA

www.visiongain.com/biosimilarsusa

6th Annual Biosimilars Conference

2nd - 4th March 2010 Boston, USA