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 rights8.30am - 12.30pmWorkshop Leaders:

Marie Manley, Partner and Head of the Regulatory Department, Bristows LLPand 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 WORKSHOPSWednesday 28th September 2016, Holiday Inn Kensington Forum, London, UK

REGISTER BY 30TH JUNE AND SAVE £200REGISTER BY 31ST AUGUST AND SAVE £100

@SMIPHARM#biosmi

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,

Biosimilars, Merck Group • Alan Sheppard, Principal, Global Generics and Biosimilars,

IMS Health • Dr Alok Sharma, Head, Bio-Analytical Development, Lupin Ltd • Dr Andrea Laslop, Head of Scientifi c Offi ce,

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

7th Annual Biosimilars EuropeDay One | Thursday 29th September 2016

Register online at: www.biosimilars-europe.com • Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Proudly Sponsored By

8.30 Registration & Coffee

9.00 Chairman’s Opening Remarks Dr Virginia Acha, Executive Director – Research, Medical

& Innovation, ABPI

OPENING ADDRESS9.10 Biosimilars: The next decade! • Achievements: in 2016 we are celebrating ten years of

biosimilars, but what have we really achieved? • Strategies & tactics: Who’s doing what in biosimilars,

where and how can biosimilar companies translate clinical and scientifi c excellence into a healthy return?

• Myths & truths: Pulling back the curtain on some of the most common misunderstandings in the biosimilars market

• The next decade: Looking beyond Europe, predicting what will happen in the US, mapping the next targets for biosimilar development

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 signifi cant savings associated with

increased competition Dr Ad Rietveld, Director, RJW & partners Ltd

10.30 Morning Coffee

TECH TALK BY SPONSOR11.00 The importance of early immunogenicity and product

quality assessment (PQA) in biosimilar development • Understanding the causes and variations of

immunogenicity between biosimilars and originators • Case study: EPO vs infl iximab switching experiences • Methods for preclinical immunogenicity and PQA

assessment for early comparative analysis • De-risking approaches for biosimilars and biobetters Laura Perry, Director of Scientifi c Affairs, Cell Line

Development, 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 CASE STUDY: The emerging biosimilars asset class – strategy & portfolio management in a VUCA (Volatile, Uncertain, Compex & Ambiguous) world

• Optimally leverage the unique characteristics of the biosimilars asset class:

- the lower risk vs original biologics while in a steady state expecting higher margin then in consumer healthcare

- the unique breadth of options for in-licensing compared to novel pharmaceuticals, i.e. potential to secure more shots at the goal

• Create a strategically agile organizational set-up for biosimilars with a high degree of decision autonomy, strong & long-term commitment from senior management

Atanas Dimitrov, Head of Strategy & Portfolio Management, Biosimilars, Merck Group

2.50 Afternoon Tea

3.20 Biologics and biosimilars: Trends and challenges • Drivers and penetration across different markets • Therapeutic positioning and need for cost savings • Effect of competition, originator response and fi rst to

market opportunities Alan Sheppard, Principal, Global Generics and Biosimilars,

IMS Health

4.00 Analytical strategies in biosimilar development • Challenges in biosimilar similarity assessment • Residual uncertainty • Newer analytical technologies • Statistical considerations Alok Sharma, Principal Scientist & Head Analytical

Development, Lupin Limited

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 OpportunitiesSMi 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 specifi c to your industry.

Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

STRATEGIC MANAGEMENT AND DEVELOPMENT

MARKET ACCESS & COMMERCIALISATION

Offi cial Media Partners

7th Annual Biosimilars EuropeDay 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 ADDRESS9.10 European regulatory update for biosimilars • Latest revisions of biosimilar guidelines

• How much clinical evidence do we need

• Lessons learned from recent approvals in Europe

Dr Andrea Laslop, Head of Scientifi c Offi ce, 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 Unifi ed 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 fi ngerprints

• 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 sponsor

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

Register online at: www.biosimilars-europe.com • Alternatively fax 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

Offi cial Publications

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 WORKSHOPWednesday 28th September 2016

08.30 – 12.30Holiday 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 refl ect on the interaction between regulatory and competition law before fi nishing. 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 certifi cates• Paediatric rewards

Programme:8.30 Registration9.00 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 specifi c to biosimilars • Circumvention of RDP9.50 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 Coffee11.00 Session 3: Supplementary Protection Certifi cates

(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 molecule11.40 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

competition12.20 Closing remarks12.30 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 fi rm 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.

B: How is the payer environment for biosimilars evolving?

Workshop Leader: Ad Rietveld, Director, RJW & partners Ltd

HALF-DAY PRE-CONFERENCE WORKSHOPWednesday 28th September 2016

13.30 – 17.30Holiday 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 the market, in particular in the EU. Although in principle welcoming 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 seeking ways of positioning biosimilars to compete effectively with 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 countries on how to build their pricing and reimbursement systems.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 EUROPEConference: Thursday 29th & Friday 30th September 2016, Holiday Inn Kensington Forum, London, UK

Workshops: Wednesday 28th September 2016, London, UK

4 WAYS TO REGISTERwww.biosimilars-europe.com

PHONE on +44 (0) 870 9090 711 1 Westminster Bridge Road, London, SE1 7XW, UK FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd