The document outlines the agenda for the 4th annual Biosimilars Conference held on March 16-17, 2010, in Brussels, Belgium, focusing on strategies for successful product launches in the biosimilars market. Key topics include current market trends, regulatory challenges, pricing strategies, and the potential of monoclonal antibody biosimilars, featuring case studies and presentations from industry experts. Attendees are encouraged to register and participate in roundtable discussions to share insights on emerging market dynamics and best practices.

1. Join our LinkedIn group
Search group name Biosimilars VIBpharma
(Practical strategies for ensuring
a successful product launch)
Biosimilars
tuesday 16 and Wednesday 17 March 2010, Brussels, Belgium
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MAIN HIGHLIGHtS INCLuDE: kEyNOtE SPEAkErS:
• Exploring current market trends and thomas Buchholz Dr Paulo Junqueira,
Partner, SIMON-kuCHEr & Medical Leader for
developments to maximise your
PArtNErS Biologic Products,
biosimilar success rOCHE PrODuCtS BrAzIL
Dr Sandro Gsteiger,
• 14 leading biotech and pharma Senior Statistical Modeller, Dr Anand Iyer, Vice
companies represented on the NOVArtIS President,
programme – delivering case study rANBAxy LABOrAtOrIES
Dr rashbehari tunga, INDIA
driven presentations Director Manufacturing,
INtAS Frank Landolt,
• Overcoming pricing and BIOPHArMACEutICAL VP Intellectual Property
reimbursement challenges to and Legal, ABLyNx N.V.
maximise the ROI of your biosimilar Anjan Selz,
CEO, FINOx Pierre-Henri Belin,
products Eprex Global
Dr Islah Ahmed, Commercial & EMEA
• Outlining the biosimilars status in Medical Director, Brand Leader,
emerging markets and how Europe HOSPIrA Strategic marketing,
can learn and benefit JANSSEN-CILAG
tOP COMPANIES rEPrESENtED INCLuDE:
1. Ablynx 4. Finox 7. Polytherics
2. Intas Biopharmaceutical 5. Hospira 8. Janssen-Cilag
3. roche Brazil 6. ranbaxy Laboratories India 9. AxiCorp
rEGIStEr NOW: ■ Email: book@arena-international.com
■ tel: +44 (0)20 7753 4268 ■ Fax: +44 (0) 20 7915 9773
register online now at: www.biosimilars-events.com

2. Programme Day One Tuesday 16 March 2010
08:30 Registration 12:20 Panel session: maximising the market share of a
biosimilar product by utilising efficient marketing and
09:00 Opening remarks from the Chair
pricing strategies to secure a market share
Critical analysis of the current market trends ● Revealing solutions to maximise public awareness of biosimilars to
achieve acceptance
and developments to understand the impact of ● Utilising different marketing tactics and channels to ensure a successful
biosimilars on the healthcare industry marketing campaign
Weighing different pricing strategies and choosing the most applicable
09:10 Measuring threats and opportunities of biosimilars – ●
one
a market barrier for mid-size companies? ● Enhancing market acceptance by utilising successful substitution processes
● Highlighting the development of your biosimilar intentions from vision
to strategy 13:00 Lunch and networking
● Outlining patient developments in a major disease challenge as
stimulus to actively enter the biosimilars market Determining the most lucrative area of the
● Exploring the strategic roadmap to success and how to overcome biosimilars market to ensure your market share
challenges and hurdles
● Identifying key levers on the way to market and how to maximise 14:00 Case study: identifying monoclonal Antibody (mAb)
their impact biosimilars as the lucrative future
● Establishing how to meet payers & customer needs to ensure a ● Outlining the potential of mAb biosimilars given the patents expiring in
successful market share the next few years
Dirk ullrich, CEO, AxICOrP ● Exploring efficacy across indications with comparative clinical trials to
ensure bioequivalence
09:50 Exploring the current legal and IP environment for ● Revealing how to successfully source enough comparator drugs to
biosimilars to ensure patent protection for originator and ensure successful and sufficient testing
biosimilar products ● Overcoming the difficulties of developing mAb biosimilars and outlining
● Outlining different patent litigation strategies to protect against the possible consequences if bioequivalence is not achieved
biosimilars ● Implementing risk management plans to avoid toxicity
● Clarifying IP implications and regulatory rules for launching a biosimilar Dr. Steffan Gross, Laboratory Head and Scientific Assessor (Quality:
to encourage biogeneric competition and reduce drug prices Non-clinical), Deputy Head Section Monoclonal and Polyclonal
● Exploring different regulatory issues to consider when seeking patent Antibodies, PEI – PAuL EHrLICH INStItutE
protection
● Examining if and which patent strategies apply for biosimilars to clarify 14:40 utilization of non human primates in biologics
the current legal environment monoclonal Antibody (mAbs) studies
● Optimising your IP strategies for biosimilar life cycle management by ● The scientific case for utilising non human primates in these types of
taking patent law and regulatory protection into account biologics/biosimilars studies
Frank Landolt, VP Intellectual Property and Legal, ABLyNx N.V. ● The diminishing returns of one-time use of a non human primate in
Marc Martens, Senior Associate, BIrD & BIrD Potential study complications of immune-mediated clinical reactions
during and after dosing in these animals
10:30 Analysing a critical approach to biosimilars and their impact ● Suggested best-practices to help prevent or address these reactions and
on the originator industry and global health industry save study data and treat the animal
● Outlining the current impact biosimilars have on the originator industry William Porter, DVM, Diplomate-American College of Laboratory Animal
and forecasting trends Medicine, former Director Laboratory Animal resources, MErCk
● Identifying legal and IP threats caused by biosimilars to understand the
economic business side 15:20 Afternoon refreshments and networking
Uncovering strategies to achieve the most effective patent protection to
●
not loose market shares
Overcoming pricing and reimbursement challenges
● Highlighting the different regulations in countries all over the world and to maximise the rOI of your biosimilar product
their impact on the quality and safety of launched biosimilars
15:50 Exploring successful pricing and reimbursement
Pierre-Henri Belin, Eprex Global Commercial & EMEA Brand Leader,
Strategic Marketing, JANSSEN-CILAG strategies in a biosimilar environment
● Understanding key drivers for a successful pricing and reimbursement
strategies
11:10 Morning refreshments and networking
● Evaluating value perception of stakeholders and its impact on pricing
and reimbursement strategies
Assessing the global legislative environment ● Understanding market access hurdles and how to overcome them
for biosimilars to understand the current market ● Forecasting market dynamics and their impact on pricing and
developments reimbursement strategies
thomas Buchholz, Partner, SIMON-kuCHEr & PArtNErS
11:40 Assessing the current WHO guidelines for biosimilars to
predict future developments Identifying challenges of biological manufacturing
● Summarising the WHO ‘biosimilar pathway’ and the controversial to overcome them and ensure bioequivalence
‘alternative pathway’ to clarify the current situation
● Reaching a global consensus on regulatory standards for biosimilars to 16:30 Case study: overcoming manufacturing challenges of
illuminate the worldwide regulatory environment biosimilars – the process defines the product
● Outlining the International non-proprietary names (INNs) requirements ● Rapid process development strategy for biosimilar product
and how they assist and improve pharmacovigilance processes ● Challenges of biological manufacturing – minor changes in the
● Uncovering efficient strategies to meet the distinct trade name manufacturing process can have major impact on product quality
requirements to successfully distinguish from originator products ● Identifying the key issues in ensuring protein drug comparability
Speaker to be confirmed, WHO – WOrLD HEALtH OrGANISAtION ● Optimising manufacturing processes to mitigate risks and ensure
biosimilarity
William Dr. rashbehari tunga, Principal Scientist,
INtAS BIOPHArMACEutICAL
17:10 Closing remarks from the Chair and close of day one

3. Programme Day Two Wednesday 17 March 2010
08:30 registration and refreshments Outlining the biosimilars status in emerging
09:00 Opening remarks from the Chair markets and how Europe can learn and benefit
14:10 Evaluating the market landscape for biosimilars
09:10 roundtable morning in emerging markets to establish threats and
Delegates will be able to attend three one-hour roundtable
discussion groups from a selection of key topics. Each session will
opportunities with focus on Latin America
● Assessing the current market share and profitability of biosimilars
be chaired by an industry expert who will facilitate an exchange of
on emerging markets
opinions, essential experiences and learning related to an aspect
● Highlighting the different regulatory systems and expectations
of biosimilars.
compared to Europe
roundtable 1 ● Discussing patient safety aspects in emerging markets and
outlining differences to Europe
Outlining the differences of global regulations and ● Uncovering business models used by successful biosimilar players
discussing the need for a global regulatory harmonisation in emerging markets to learn from their experience
to achieve acceptance of biosimilars ● Understanding why emerging market biosimilars are not launched
Dr Anand Iyer, Vice President, rANBAxy LABOrAtOrIES INDIA in Europe yet
Dr. Paulo Junqueira, Medical Leader for Biologic Products, rOCHE
roundtable 2 PrODuCtS BrAzIL
understanding the biosimilars market in emerging markets
14:50 Case study: essential lessons learned from the
such as China, India and Latin America to discuss what we
development and launch of biosimilars in emerging
can learn from other market developments
Dr. Paulo Junqueira, Medical Leader for Biosimilars, Pharmacology, markets
rOCHE PrODuCtS BrAzIL ● Outlining the R&D and testing processes and differences to Europe
● Uncovering strategies to achieve regulatory approval to ensure
roundtable 3 market access
● Identifying efficient market entry strategies to ensure acceptance and
Determining monoclonal antibodies and their potential ROI
as biosimilars as patents are running out for originator ● Considering regulatory, manufacturing and pricing differences to
products develop successful strategies to enter the European market
Dr .Steffen Gross, Laboratory Head and Scientific Assessor (Quality: Dr Anand Iyer, Vice President, rANBAxy LABOrAtOrIES INDIA
Non-clinical), Deputy Head Section Monoclonal and Polyclonal
Antibodies, PEI – PAuL EHrLICH INStItutE 15:30 Afternoon refreshments
roundtable 4 Implementing risk management plans and
Conducting a SWOt analysis for the global biosimilar pharmacovigilance strategies to mitigate risks
market to identify threats and opportunities and forecast
future trends
and ensure patients safety
Anjan Selz, CEO, FINOx 16:00 Enhancing effectiveness and mitigating risks for
patients by putting efficient pharmacovigilance
12:30 Lunch and networking and risk management strategies in place
● Evaluating the potential risks of biosimilars to implement efficient
risk management and pharmacovigilance strategies in place to
Examining the emerging market for biobetters to increase drug safety
exploit its potential and to ensure market shares ● Outlining the current status of characterisation processes of
13:30 Biosimilars versus biobetters – positioning for a new biosimilars and how they improved over the past decade
● Mitigating the risk of adverse events by utilising effective
market with lucrative prospects traceability strategies
● Outlining the benefits of second generation biosimilars (biobetters)
● Building a post-marketing educational system to rise public
over the first-generation products to clearly understand the market
awareness and acceptance
● Uncovering the current biobetter market and underlining the potential
Dr Islah Ahmed, Medical Director, HOSPIrA
with facts and figures
● Identifying the potential of biobetters to be accepted more readily by
end-users and over-exceed the originator products revenue Exploring established and novel analytical tools
● Overcoming concerns of bioequivalence to make biobetters more to maximise comparability demonstration
attractive to the global health industry
● Learning from Germany how to incentivise biosimilar usage to get
16:40 Case study: overcoming manufacturing challenges of
access to this lucrative market biosimilars – the process defines the product
keith Powell, CEO, POLytHErICS ● Exploring effective comparator sourcing strategies to ensure
sufficient supplies of the original drug
● Identifying new and established analytical tools to demonstrate
comparability
● Mitigating risks of immunogenicity to avoid adverse events
REGISTER ONLINE NOW!
● Assessing ways to cut costs and save time while still ensuring
patients safety
● Analysing the current regulations for comparability of biosimilar
www.biosimilars-events.com/ products
Dr. Sandro Gsteiger, Senior Statistical Modeller, NOVArtIS
register.asp 17:20 Closing remarks from the Chair
Book before the 23rd December 17:25 Champagne prize draw
and save €490 17:30 Close of conference

4. Media partners
Who should attend Pharmaceutical technology is
The audience will be made up of senior used daily as a means of creating
representatives from biotech and pharmaceutical partnerships and as a point of
companies working within the following areas: reference by professionals within the pharmaceutical industry.
This comprehensive resource supplies the latest news
● Regulatory Affairs releases, detailed information on industry projects, white
● Medical Affairs papers, event information and a thorough breakdown of
● Product Development products and services. www.pharmaceutical-technology.com
● Business Development Pharmaceutical Business review. The
Business Review websites are your number
● Preclinical and Clinical Development
one stop for all the latest news, comment
● Strategy and industry information. Each Business
● Analytics Review website offers content that is produced by a dedicated team
of journalists and global industry experts.In addition to the free
● Scientific Affairs
content made available on the sites an intelligence store will provide
● Strategic Planning you with premium market analysis reports from the leading global
● Business Strategy suppliers of market research and industry analysis.Pharmaceutical
Business Review is the world's leading pharma website, being used
● Corporate Development Strategy by over 100,000 visitors every month. For further information contact
● Research and Development jsharp@industryreview.com
Medical etrack is the new,
interactive desktop tool
About the conference designed for executives & analysts active in or supplying
services to the medical equipment industry. www.
In an environment where resources are scarce medicaletrack.com
and patents are fast expiring, effective product Generics bulletin is the global generic
planning is paramount to ensuring the success of industry’s essential source of news
your organisation. Biologic drugs - noted as some and views on product launches,
of the most-expensive medicines - are major targets company deals, regulatory changes and patent pricing and
for cost savings. The developments facilitating reimbursement issues. Two formats: a weekly electronic
newsflash and a twice-monthly paper publication provide both
follow-on biologics are gaining momentum, with
immediacy and depth from a generics industry perspective. For
significant commercial opportunities emerging. further information please visit www.generics-bulletin.com or
Significant barriers to entry exist in the biosimilars contact Val Davis at davis@generics-bulletin.com or call +44
(0)1564 777550.
market. Significant initial investment and the
need for specific expertise favour big players. This information portal is a joint
Understanding of the marketplace is critical project by the federal agencies CTI/
for success, acceptance by key stakeholders is KTI (Commission for Technology and
Innovation), seco and BBT. The federal partners were joined
crucial for market uptake of biosimilars. Achieving
by the members of the Swss Life Science Marketing Alliance
preferential reimbursement status through (Cluster Initiatives Basel Area for Life Sciences, Bio Alps, Bio
constant review of the pricing strategy is essential. Polo Ticino, Greater Zurich Area, the SWX Swiss Exchange and
Swiss Biotech Association, the national industry association.
Following on the success of our 3rd Biosimilars
www.swissbiotech.org/home
conference VIBpharma is proud to announce the
4th annual Biosimilars conference taking place Drug Development technology is a
on Tuesday 16 and Wednesday 17 March 2010 in procurement and reference resource
providing a one-stop-shop for professionals and decision
Brussels, Belgium.
makers within the drug development and medicines industry.
Through a series of presentations and interactive We provide a comprehensive breakdown of drug development
discussions covering key issues such as current contractors and suppliers, up-to-date news and press releases,
market trends, biobetters, the global regulatory white papers and detailed information on current industry
projects and trends. Our recruitment area provides career
environment, pricing and reimbursement strategies
information and the latest job vacancies in the field. www.
and biosimilars in emerging markets, participants drugdevelopment-technology.com
will gain new insight and share hands-on
experiences with leading companies in the pharma World Pharmaceutical Frontiers
The pharmaceutical industry is
World Pharmaceutical Frontiers www.worldpharmaceuticals.net
and biotech industry.
changing fast. There are more regulations, technologies, faster
product launches and shorter product life cycles than ever
before. World Pharmaceuticals frontiers is, and will continue
to be, at the forefront of these changes, so visit us at www.
If you want to be a part of this successful worldpharmaceuticals.net and stay up to date with all latest
developments
event, we have a number of sponsorship
opportunities available.
Contact Paul Adams to discuss your specific requirements
pauladams@arena-international.com or call +4420 7753 4259

5. BOOkING FOrM
Biosimilars, Tuesday 16 and Wednesday 17 March 2010, Brussels, Belgium
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