This document provides information about two pre-conference workshops for the 7th Annual Biosimilars Europe conference. The first workshop focuses on maximizing intellectual property and regulatory rights related to biosimilars. It will cover topics like regulatory data protection, orphan drug exclusivity, supplementary protection certificates, and pediatric rewards. The workshop leaders are partners at Bristows LLP. The second workshop examines how the payer environment for biosimilars is evolving. It will provide insight into pricing, reimbursement, and formulary access processes. Case studies will also be presented on successful biosimilar launches. The workshop leader is the director of RJW & Partners Ltd, a pricing and market

1. www.biosimilars-europe.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
Biosimilars: Maximisation of IP regulatory rights
8.30am - 12.30pm
Workshop Leaders:
Marie Manley, Partner and Head of the Regulatory Department, Bristows LLP
and Libby Amos, Associate, Regulatory Department, Bristows LLP
How is the payer environment for biosimilars evolving?
1.30pm - 5.30pm
Workshop Leader:
Dr Ad Rietveld, Director, RJW & partners Ltd
TWO INTERACTIVE PRE-CONFERENCE HALF-DAY WORKSHOPS
Wednesday 28th September 2016, Holiday Inn Kensington Forum, London, UK
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SMi presents Europe’s leading 7th annual conference
Biosimilars Europe
Holiday Inn Kensington Forum, London, UK
The latest updates on regulation, market access
strategies and improvement of commercialisation
Proudly Sponsored By:
Chair:
• Dr Virginia Acha, Executive Director – Research,
Medical & Innovation, ABPI
2016 Featured Speakers:
• Huiguo Hu, General Manager of International Business,
Shanghai CP Guojian Pharmaceutical Co. Ltd
• Dr Niraj Chhaya, Risk Management,
Boehringer Ingelheim GmbH
• Atanas Dimitrov, Head of Strategy & Portfolio Management,
Merck Group
• Dr Alok Sharma, Head, Bio-Analytical Development, Lupin Ltd
• Dr Andrea Laslop, Head of Scientific Office,
Austrian Agency for Health and Food Safety
• Joan O’Callaghan, Research Scientist for
Regulatory Science Ireland,
Health Products Regulatory Authority, Ireland
Exclusive Highlights in 2016:
• Hear how the evolving regulatory landscape and
guidelines will impact on biosimilars
• Overcome market access and commercialisation barriers
• Assess market trends and align your business strategy on
emerging markets
• Technical updates on protein characterisation and
analytical comparability to speed up data collection
WORKSHOPS: 28TH
CONFERENCE: 29TH - 30TH
SEPT 2016

2. 7th Annual Biosimilars Europe
Day One | Thursday 29th September 2016
Register online at: www.biosimilars-europe.com • Alternatively fax
Proudly Sponsored By
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Dr Virginia Acha, Executive Director – Research, Medical
& Innovation, ABPI
OPENING ADDRESS
9.10 The biosimilars market - current status and future
projections
• Understand how the global pharmaceutical market is
becoming more specialised and precise
• Biosimilars experience to date and the future assessment
• Most successful therapeutic areas for gaining approval
and acceptance
Dr Duncan Emerton, Senior Director, Syndicated Insights
& Analysis, FirstWord
9.50 The effects of biosimilar competition across Europe
• Biological medicines market underpins the potential for
healthcare savings and increased access
• Product availability in each therapeutic area
• Correlation between biosimilars market share and price
erosion of biological medicines
• Potential for significant savings associated with
increased competition
Dr Ad Rietveld, Director, RJW & partners Ltd
10.30 Morning Coffee
TECH TALK BY SPONSOR
11.00 The importance of early immunogenicity and Product
Quality (PQA) assessment in biosimilar development
• Understanding the causes and variations of
immunogenicity between biosimilars and originators
• Case study: EPO vs infliximab switching experiences
• Methods for preclinical immunogenicity and PQA
assessment for early comparative analysis
• De-risking approaches for biosimilars and biobetters
Laura Perry, Senior Project Manager, Abzena
11.40 Strategies to enter the emerging markets
• Regulation situation and guidelines listing
• Pricing and reimbursement
• Challenges and key success factors
Huiguo Hu, General Manager of International Business,
Shanghai CP Guojian Pharmaceutical Co. Ltd
12.20 Networking Lunch
1.30 Biosimilars – the second translational gap
• Incorporating biosimilars into healthcare practice is the
next translational challenge
• In the UK, NHS England leads a multi-stakeholder
coordinating group to address this
• Success through training and guidance and effective
competition is delivering results
Dr Virginia Acha, Executive Director – Research,
Medical & Innovation, ABPI
2.10 An update on Indian biosimilar market
Dr Alok Sharma, Head, Bio-Analytical Development,
Lupin Ltd
2.50 Afternoon Tea
3.20 Key considerations in biosimilars development
• Strategic development
• Clinical characterisation
• Pharmacovigilance
Atanas Dimitrov, Head of Strategy and Portfolio
Management, Merck Group
4.00 Clinical updates and the latest biosimilar developments
• Biosimilar versions of a monoclonal antibody (mAb) drug
• Quality, safety and efficacy assessment for investors
• The effect on cash-strapped healthcare systems across
Europe
Dr Karsten Roth, Director Clinical Operations,
Cinfa Biotech GmbH*
4.40 Chairman’s Closing Remarks and Close of Day One
Abzena offers a suite of complementary services and technologies. Its range of technologies include
immunogenicity assessment, antibody drug conjugation, protein engineering, PEGylation, cell line development,
GMP manufacturing and a range of bespoke assays to enables the development of better biopharmaceuticals
which will have a greater chance of reaching the market. www.abzena.com
Sponsorship and Exhibition Opportunities
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry.
Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168
or email: amalick@smi-online.co.uk
PRE-CLINICAL & CLINICAL DEVELOPMENT
MARKET ACCESS & COMMERCIALISATION
*Subject to final confirmation

3. 7th Annual Biosimilars Europe
Day Two | Friday 30th September 2016
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Dr Virginia Acha, Executive Director – Research,
Medical & Innovation, ABPI
OPENING ADDRESS
9.10 European regulatory update for biosimilars
Dr Andrea Laslop, Head of Scientific Office, Austrian
Agency for Health and Food Safety
9.50 Regulatory Science Ireland: Biosimilars research project
• Prescriber attitudes and behaviours towards
biosimilar medicines
• Reducing the information gap
• Comparison of international models for providing
safe and effective supply of biosimilar medicines
Joan O’Callaghan, Research Scientist
for Regulatory Science Ireland (RSI),
Health Products Regulatory Authority, Ireland
10.30 Morning Coffee
11.00 KEYNOTE ADDRESS
From biosimilars to biogenerics?
• Uptake of biosimilars in clinical practice
• The importance of switching
• Switching - clinical trials and practical experiences
Dr Steinar Madsen, Medical Director,
Norwegian Medicines Agency
11.40 Litigation update: Europe and the US
• A look at the latest biosimilar litigation cases from the UK
and the US
• Assessing the drivers, strategy and outcomes
• Looking ahead to future disputes and a new European
landscape: the Unified Patent Court
Dr Dominic Adair, Partner, Bristows LLP
12.20 Networking Lunch
KEYNOTE ADDRESS
1.30 Robust Pharmacovigilance: A key to successful biosimilars
• Guidelines for biosimilar pharmacovigilance in the EU
and USA
• Key considerations: Immunogenicity, interchangeability,
traceability
• Risk management plans for biosimilars
Dr Niraj Chhaya, Risk Management,
Boehringer Ingelheim GmbH
2.10 Looking for fingerprints
• Bioanalytical characterisation - developing a robust and
comparative structural and functional study between
innovator and originator
• From physical to chemical: What are the parameters
and how to showcase similarities?
• Technology breakthrough: Yielding 3D structure of
monoclonal antibodies at atomic-level
• Reliability and repeatability for regulators’ approvals
Reserved for Big Pharma Company
2.50 Afternoon Tea
3.20 The increasing importance of medical devices for
regulatory and commercial success of biosimilars
• Biosimilars offer very few opportunities for differentiation
• Autoinjectors and other medical device components
are the only area, where biosimilars can offer additional
value and differentiate
• Originators and biosimilar developers are facing an
“arms race” with medical devices to secure
Dr Dirk Kreder, CEO, Anteris medical GmbH
4.00 Chairman’s Closing Remarks and Close of Day Two
your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk
Supported by
REGULATORY AND LITIGATION UPDATES ON BIOSIMILARS IN EUROPE
TECHNOLOGICAL DEVELOPMENTS
Official Media Partners

4. Biosimilars: Maximisation of IP
regulatory rights
Workshop Leaders:
Marie Manley, Partner and Head of the Regulatory
Department, Bristows LLP and Libby Amos, Associate,
Regulatory Department, Bristows LLP
HALF-DAY PRE-CONFERENCE WORKSHOP
Wednesday 28th September 2016
08.30 – 12.30
Holiday Inn Kensington Forum, London, UK
Overview of workshop:
A full workshop covering all aspects of pharmaceutical
regulation applicable to biosimilars. The workshop will
begin with an explanation of the interplay between the
various IP regulatory rights in the EU and then look at each
in detail. The workshop will also reflect on the interaction
between regulatory and competition law before finishing.
An interactive case study will be run throughout the topics
of the workshop to test the knowledge gained.
Why should you attend this workshop:
To gain knowledge of:
• Regulatory Data Protection
• Market exclusivity for orphan medicinal products
• Supplementary protection certificates
• Paediatric rewards
Programme:
8.30 Registration
9.00 Opening remarks and introductions
9.10 Session 1: Regulatory Data Protection (RDP)
• What RDP rights are available in the EU?
• RDP and marketing protection in a nutshell
• Case study: Calculating the period of RDP
• Hot issues and grey areas specific to biosimilars
• Circumvention of RDP
9.50 Session 2: Orphan medicinal products
• Orphan market exclusivity
• Case study: Duration of market exclusivity
• Derogations to market exclusivity
• Strategic issues and practical implications
10.30 Coffee
11.00 Session 3: Supplementary Protection Certificates
(SPCs)
• What is an SPC and why do we need them?
• Scope of the SPC regulation
• Conditions for obtaining an SPC
• Duration of the SPC
• Case study: Calculating the SPC
• Particular considerations for a
biotechnological molecule
11.40 Session 4: The Paediatric Regulation and
summary of workshops
• Interaction with the SPC Regulation
• Rewards under the paediatric regulation
• Life Cycle Management – an overview of IP
rights
• Interaction between regulatory and
competition
12.20 Closing remarks
12.30 End of workshop
About the Workshop Leaders:
Marie Manley is a Partner and head of the IP
Regulatory Department at Bristows LLP (London).
She advises on both contentious and non-
contentious matters, focusing on regulatory and
competition law in the bio-pharma, medical
devices, cosmetic and food sectors; including life
cycle management issues, advertising and product liability.
Marie is Chairperson of the Legal Affairs Community for DIA.
Marie is considered as a leading practitioner for regulatory
law and is described by clients as a “regulatory superstar”.
She is recommended in Legal 500, Chambers and Partners;
also London Top 100 & London Top 50 Women and EU Law &
Super Lawyers UK(2013).
Libby Amos is an associate in the IP Regulatory
department advising clients on both contentious
and non-contentious EU and UK regulatory
matters.
Libby is currently advising a leading
pharmaceutical company on an appeal against a
Commission Decision alleging violations of Articles 101
and 102 TFEU. Libby has recently co-authored chapters
on authorisation and advertising of medicinal products
for the newly published textbook, Navigating European
Pharmaceutical Law.
About the Bristows:
Bristows is a full service London law firm serving innovative
companies and industry leaders around the world. Bristows
has a true cross-disciplinary Life science team of over
60 lawyers in this space encompassing our renowned
IP practice, regulatory, competition, commercial,
transactional and IT/data protection teams. The strength of
each individual practice complements the others to provide
a fully integrated service.
Many of Bristows life sciences specialists have backgrounds
in chemistry, biochemistry, biotechnology, physics and
engineering.

5. B: How is the payer environment for
biosimilars evolving?
Workshop Leader:
Ad Rietveld, Director, RJW & partners Ltd
HALF-DAY PRE-CONFERENCE WORKSHOP
Wednesday 28th September 2016
13.30 – 17.30
Holiday Inn Kensington Forum, London, UK
Overview of Workshop:
The regulatory barriers for the launch of biosimilars seem to have
been overcome with a growing number of products coming to
themarket,inparticularintheEU.Althoughinprinciplewelcoming
the introduction of biosimilars and thus more competition, payers
are still contemplating how to make use of biosimilars to drive
cost of biologicals down. At the same time, manufacturers are still
seekingwaysofpositioningbiosimilarstocompeteeffectivelywith
the originator biologicals.
The workshop will examine the current state of affairs and take a
look into what the future may bring with a focus on the changing
payer environment.
Why should you attend this workshop:
• Gain insight from highly experienced professionals and
colleagues
• Understand the payer environment for biosimilars in different
markets
• Be able to make founded predictions for the future payer
environment
• Enrich your ideas on how to launch biosimilars successfully or
defend your originator product successfully against biosimilar
competition.
Programme:
1.30 Registration and Coffee
2.00 Opening remarks and introductions
2.10 Session 1: Biosimilars: why is regulatory approval still
not enough to achieve sales?
• Biosimilars vs generics – a similar level of success?
• Outline of the pricing, reimbursement and
formulary access process
• The real hurdles to biosimilar sales
2.50 Session 2: The payer perspective: biosimilars are
what we’ve been waiting for!
• Growing demand and rising expenditure
• Specialty care products are the biggest cost area
• The impact of geography – Europe vs US
• Payer attitudes to biosimilars
• Payer developments with respect to biosimilars
3.30 Afternoon Tea
4.00 Session 3: How to ensure that evidence for biosimilars
is relevant to the payer
• Expectations of evidence in support of pricing and
access
• Are biosimilars a special case when it comes to
evidence?
• How payers look at value - it’s not all about cost-
effectiveness
• Getting over the last hurdle to ensure prescriber
buy-in
4.40 Session 4: Case studies
• Selection of case studies on biosimilar introductions
5.20 Closing remarks
5.30 End of workshop
About the Workshop Leader:
Ad Rietveld is a former GP with marketing
experience in the industry (Solvay) and extensive
consulting experience in pricing and market access
(Cambridge/IMS).
Ad was a former national payer in the Dutch Ministry of Health
and has been a Consultant to World Bank, EU and WHO, advising
countriesonhowtobuildtheirpricingandreimbursementsystems.
In 2008, Ad co-founded RJW & partners Ltd, a consultancy that
provides pricing and market access services to pharmaceutical
and medical device companies.
About the Organisation:
RJW & partners Ltd is a UK-based Consultancy with presence in
Europe, US and Australia. RJW & partners provide strategic pricing
and market access advice to pharmaceutical and medical
device companies of all sizes. RJW & partners services cover all
geographies and therapy areas.

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VENUE Holiday Inn Kensington Forum, 97 Cromwell Rd, London SW7 4DN, UK
BIOSIMILARS EUROPE
Conference: Thursday 29th & Friday 30th September 2016, Holiday Inn Kensington Forum, London, UK
Workshops: Wednesday 28th September 2016, London, UK
4 WAYS TO REGISTER
www.biosimilars-europe.com
FAX your booking form to +44 (0) 870 9090 712
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