Chair: TWO INTERACTIVE PRE-CONFERENCE HALF-DAY WORKSHOPS Wednesday 28th September 2016, Holiday Inn Kensington Forum, London, UK

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1 REGISTER BY 30TH JUNE AND SAVE 200 REGISTER BY 31ST AUGUST AND SAVE 100 SMi presents Europe s leading 7th annual conference Biosimilars Europe Holiday Inn Kensington Forum, London, UK WORKSHOPS: 28TH CONFERENCE: 29TH - 30TH SEPT 2016 The latest updates on regulation, market access strategies and improvement of commercialisation 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 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 TWO INTERACTIVE PRE-CONFERENCE HALF-DAY WORKSHOPS Wednesday 28th September 2016, Holiday Inn Kensington Forum, London, UK Biosimilars: Maximisation of IP regulatory rights 8.30am pm 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 pm Workshop Leader: Dr Ad Rietveld, Director, RJW & partners Ltd Proudly Sponsored By: Register online or fax your registration to +44 (0) or call +44 (0) ACADEMIC & GROUP DISCOUNTS #biosmi

2 7th Annual Biosimilars Europe Day One Thursday 29th September Registration & Coffee 9.00 Chairman s Opening Remarks Dr Virginia Acha, Executive Director Research, Medical & Innovation, ABPI OPENING ADDRESS 9.10 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 Morning Coffee MARKET ACCESS & COMMERCIALISATION TECH TALK BY SPONSOR 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 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 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 STRATEGIC MANAGEMENT AND DEVELOPMENT 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 Proudly Sponsored By Official Media Partners 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. 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 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) or amalick@smi-online.co.uk Register online at: Alternatively fax

3 7th Annual Biosimilars Europe Day Two Friday 30th September Registration & Coffee 9.00 Chairman s Opening Remarks Dr Virginia Acha, Executive Director Research, Medical & Innovation, ABPI REGULATORY AND LITIGATION UPDATES ON BIOSIMILARS IN EUROPE OPENING ADDRESS 9.10 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 Morning Coffee 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 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 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 TECHNOLOGICAL DEVELOPMENTS 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 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 Networking Lunch 4.00 Chairman s Closing Remarks and Close of Day Two Official Publications Supported by Want to know how you can get involved? Interested in promoting your services to this market? Contact Teri Arri, SMi Marketing on +44 (0) or tarri@smi-online.co.uk your registration to +44 (0) or call +44 (0)

4 HALF-DAY PRE-CONFERENCE WORKSHOP Wednesday 28th September Holiday Inn Kensington Forum, London, UK 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 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 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 specifi c 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 Coffee 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 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 Closing remarks 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 noncontentious 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.

5 HALF-DAY PRE-CONFERENCE WORKSHOP Wednesday 28th September Holiday Inn Kensington Forum, London, UK B: How is the payer environment for biosimilars evolving? Workshop Leader: Ad Rietveld, Director, RJW & partners Ltd 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 costeffectiveness 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.

6 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 FAX your booking form to +44 (0) POST your booking form to: Events Team, SMi Group Ltd PHONE on +44 (0) Westminster Bridge Road, London, SE1 7XW, UK EARLY BIRD DISCOUNT Book by 30th June to receive 200 off the conference price Book by 31st August to receive 100 off the conference price Unique Reference Number Our Reference DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Surname: Job Title: Forename: Department/Division: Company/Organisation: Company VAT Number: Address: Town/City: Post/Zip Code: Direct Tel: Mobile: Switchboard: Signature: Country: Direct Fax: I agree to be bound by SMi s Terms and Conditions of Booking. 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