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Day 1 Market Access Strategies, Opportunities, Clinical Development and Commercial Challenges Assessing the landscape of biosimilars: interchangeability and substitution Evaluating the current market

Eastern Europe), Asia and USA Clinical advances in biosimilars Biosimilar medicines in clinical use Day 2 Developing Biosimilars and Biobetters Manufacturing and Bio- Analytics Demonstrating

Purification and analysis, including; o ADC activities Ensuring the quality of follow-on biologics: analytical testing, downstream processing Analytical development and formulation strategies for

1 Day 1 Market Access Strategies, Opportunities, Clinical Development and Commercial Challenges Assessing the landscape of biosimilars: interchangeability and substitution Evaluating the current market for biosimilar success: challenges, opportunities and barriers Regulatory updates on biosimilars Case studies on commercialisation strategies Europe (esp. Eastern Europe), Asia and USA Clinical advances in biosimilars Biosimilar medicines in clinical use Day 2 Developing Biosimilars and Biobetters Manufacturing and Bio- Analytics Demonstrating biosimilarity: challenges and solutions Characterisation methods: physiochemical characterisation, structural characterisation, glycosylation analysis Affordability and In time production Purification and analysis, including; o ADC activities Ensuring the quality of follow-on biologics: analytical testing, downstream processing Analytical development and formulation strategies for follow-on biologics Updates in quality control and safety for manufacturing Benefits to Attending Hear from and meet with the key innovators involved in biosimilar regulation, commercialisation and development. Attendees include: Program Director Biosimilars, Boehringer Ingelheim; Global Head Medical Affairs, Biogen Idec; Director, Biosimilars & Biologics, Abbvie Discover the latest commercialisation and market access strategies, join key debates on the recent clinical developments in the biosimilar and biobetter industry with case studies from the leading experts Hear the latest insights into successful manufacturing techniques and tools in analytical testing, purification and characterisation, as well as assessing quality control and in time production methods Discuss recent advances in the regulatory landscape for biosimilars. Get updated on the most recent legal developments, identify the key advances in approaches to safety requirements, and address the outstanding issues and possibilities for biosimilar regulation Unparalleled networking opportunities. The two-day congress offers dedicated networking breaks creating an interactive platform for knowledgesharing, with 1-1 meetings, exhibition hall, exciting poster presentations and our ever popular drinks reception A high quality programme devised with the help of our esteemed advisory board. Presentations will cover areas including approaches to regulatory challenges, global opportunities in the biosimilar market and the latest clinical case studies 2018 Webinars Include: Biosimilars: The Cancer Patient Perspective. Tuesday 13 th February Register for free here Speakers Include: Co-located with our prestigious 11 th Annual Proteins & Antibodies Congress and 5 th Annual Peptides Congress Katalin Egyed Michael Bayewitch Isabell Remus EGIS Teva Pharmaceuticals Sandoz International Pharmaceuticals Meet Senior Decision Makers 450 VPs, Directors & Senior Managers from leading pharmaceutical organisations, biotech companies and academic institutions will attend the event. Delegate job titles include: Commercial Affairs Clinical Development Follow-On Biologics Biologics Development Strategic Marketing Regulatory/Legal Affairs Commercial Development Medical Affairs Market Access Biosimilars Biobetters Biosuperiors Discover New Solutions Formal and informal meeting opportunities offer delegates the chance to discuss key solutions with leading service providers. Services to be discussed include: Biologics 2016 Safety Speakers Testing Include: Biologics Manufacturing Assay Development Regulatory Affairs Biosimilar Analysis Biosimilar Trial Design Extrapolation Characterisation Stability Testing Strategy Planning Quality Assurance Clinical Outsourcing For booking details & registration fees please refer to the last page or visit:

Confirmed Speakers Include: Andrea Bean, Director, Biosimilars, Amgen Isabell Remus,

Regulatory Policy and Intelligence, Abbvie Javier Coindreau, Vice President Global

Senior Director, Global Search & Evaluation, Biologics, Teva Pharmaceuticals Orit

Industries Silke Ruzek, Lab Head Physico-Chemical Characterization, Novartis Niraj

Katalin Egyed, Head of International Oncology and Biosimilar Marketing Division, EGIS

Officer, Baliopharm Jonathan Underhill, Medicines Consultant Clinical Adviser, NICE -

Pharmacist, Specialist Pharmacy Services, NHS John Klimek, Senior Vice President,

Webber, Patent Attorney, Dehns Patent and Trade Mark Attorneys Gregory Glover,

Steinar Madsen, Medical Director, Norwegian Medicines Agency Theo Christie, Business

of Geneva 2018 Proteins & Antibodies, Biosimilars & Biobetters and Peptides Congress

2 Confirmed Speakers Include: Andrea Bean, Director, Biosimilars, Amgen Isabell Remus, Head Biosimilars Western Europe, Sandoz International Keith Watson, Director, Regulatory Policy and Intelligence, Abbvie Javier Coindreau, Vice President Global Medical Affairs, Biosimilars, Immunology and Oncology, Pfizer Michael Bayewitch, Senior Director, Global Search & Evaluation, Biologics, Teva Pharmaceuticals Orit Aharonovitz, Senior Director, Cell Line & Process Development, Teva Pharmaceutical Industries Silke Ruzek, Lab Head Physico-Chemical Characterization, Novartis Niraj Chhaya, Senior Risk Management Physician, Global Pharmacovigilance, Boehringer Ingelheim International Inc. Andrew Roberts, Director of Market Access & External Affairs, Napp Pharmaceuticals Katalin Egyed, Head of International Oncology and Biosimilar Marketing Division, EGIS Rafal Derlacz, Senior Project Manager, Polpharma Andreas Herrmann, Chief Executive Officer, Baliopharm Jonathan Underhill, Medicines Consultant Clinical Adviser, NICE - National Institute for Health and Care Excellence James Kent, Specialist Procurement Pharmacist, Specialist Pharmacy Services, NHS John Klimek, Senior Vice President, Standards and Industry IT, National Council for Prescription Drug Programs Philip Webber, Patent Attorney, Dehns Patent and Trade Mark Attorneys Gregory Glover, Attorney at Law, Pharmaceutical Law Group PC Brian Carey, Partner, Foley Hoag LLP Steinar Madsen, Medical Director, Norwegian Medicines Agency Theo Christie, Business Development and Marketing Manager, NIHR CRN Tudor Arvinte, Professor, The University of Geneva 2018 Proteins & Antibodies, Biosimilars & Biobetters and Peptides Congress Sponsors Include: Gold Sponsors: Bronze Sponsors: Event Sponsors: If you re on Twitter, make sure to follow and join the Proteins, Peptides and Biosimilars conversation on #BIOSIM18

Event Sponsors Continued: Documentation Sponsor: 5 th Annual

30 Chairperson s Opening Address: Aditya Bahl, Director, RAS LSS

00 Co-Located Keynote Address: Advanced Protein Technologies To

Ai Ching Lim, Director, Research, Amgen Market Access

Challenges Stream Chair: Aditya Bahl, Director, RAS LSS

30 Stream Keynote Address: Interchangeability - Some Points To

of interchangeability Lifecycle management of interchangeability

3 Event Sponsors Continued: Documentation Sponsor: 5 th Annual Biosimilars & Biobetters Congress Day One 16 th April Registration Oxford Global s Welcome Address Chairperson s Opening Address: Aditya Bahl, Director, RAS LSS Consulting Co-Located Keynote Address: Advanced Protein Technologies To Supporting Discovery Reagents For Early Stage Biologics Program Ai Ching Lim, Director, Research, Amgen Market Access Strategies, Opportunities, Clinical Development And Commercial Challenges Stream Chair: Aditya Bahl, Director, RAS LSS Consulting Stream Keynote Address: Interchangeability - Some Points To Consider Regulatory positions on interchangeability Assessment of interchangeability Lifecycle management of interchangeability Keith Watson, Director, Regulatory Policy and Intelligence, Abbvie Title To Be Confirmed Aditya Bahl, Director, RAS LSS Consulting Morning Coffee & Refreshments, One to One Meetings x3, Poster Presentation Sessions

4 5 th Annual Biosimilars & Biobetters Congress Day One 16 th April Drivers And Challenges Of Successful Biosimilar Business - 5 Year Real Time Market Access, Marketing And Commercial Experiences With Biosimilars In CEE-CIS Region Factors impacting biosimilar adoption: how evolution of acceptance of biosimilar paradigm and interchangeability of biosimilars were developed and supported by alive long term experiences Key elements and optimal approach of successful market access, marketing and commercialization strategy to manage supporting factors and hurdles on different stakeholder levels Consequences and approach solutions for sustainable long term biosimilar business Katalin Egyed, Head of International Oncology and Biosimilar Marketing Division, EGIS Uptake Of Biosimilars; Support On A National And Local Level How NICE deals with new biosimilars Procurement issues at a National, regional and local level Supporting the adoption of biosimilars at a local level with examples of best practice and shared learning Joint Presentation: Jonathan Underhill, Medicines Consultant Clinical Adviser, NICE - National Institute for Health and Care Excellence And James Kent, Specialist Procurement Pharmacist, Specialist Pharmacy Services, NHS Solution Provider Presentation: Reserved Lunch, Poster Presentation Sessions Biosimilars Non-Proprietary Naming Help Patient Safety Or Confusion? About NCPDP and their role in HealthCare Why standards are important in industry Discuss FDA decision on suffix for biosimilars and how this is different from the norm NCPDP s Task Group discussion and recommendations Work efforts to comply with suffix and patient safety concerns when biosimilars are dispensed John Klimek, Senior Vice President, Standards and Industry IT, National Council for Prescription Drug Programs Commercialization And Manufacture Of PF In The 28 Countries That Form The European Economic Area (EEA) Isabell Remus, Head Biosimilars Western Europe, Sandoz International Solution Provider Presentation For sponsorship opportunities please contact sponsorship@oxfordglobal.co.uk Afternoon Coffee & Refreshments, One to One Meetings x 2, Poster Presentation Sessions Patenting Of Biosimilars And Biobetters Whilst biosimilars need to be clinically similar to the reference product, there are still opportunities to patent new processes and formulations Biobetters will be novel over the reference product, but how different does the biobetter have to be to make it inventive? This presentation will discuss the criteria for patenting new biotech products, processes and methods Philip Webber, Patent Attorney, Dehns Patent and Trade Mark Attorneys Real World Evidence For Biosimilars Guidance on Real World Evidence (RWE) from regulatory agencies Challenges around gathering RWE Interpretation of RWE Niraj Chhaya, Senior Risk Management Physician, Global Pharmacovigilance, Boehringer Ingelheim International Inc Market Exclusivity Issues for Biologics and Biosimilars Beyond the Hatch-Waxman Paradigm Practical Implications of the Exclusivity Provisions Unresolved Issues for Consideration Gregory Glover, Attorney at Law, Pharmaceutical Law Group PC

5 5 th Annual Biosimilars & Biobetters Congress Day One 16 th April Napp Launches Truxima (Rituximab), The First Biosimilar Monoclonal Antibody For The Treatment Of Cancer In The UK Andrew Roberts, Director of Market Access & External Affairs, Napp Pharmaceuticals Launching Biosimilars In The US Market: Update On The Regulatory And Reimbursement Environment Recent experience with FDA approval pathway for biosimilars under the Biologics Price Competition and Innovation Act Overview of the current reimbursement environment for biosimilars under Medicare Parts B and D and commercial insurers and implications for biosimilar launch in US Analysis of recent developments in reimbursement for biosimilars under Medicare, including unique codes and separate payment for biosimilars with the same reference product Brian Carey, Partner, Foley Hoag LLP Networking Drinks and End of Day One Congress Dinner 5 th Annual Biosimilars & Biobetters Congress Day Two 17 th April Breakfast Think Tank Round Table Discussions Table 1 Market Access Strategies, Clinical Development And Commercialisation Invitation to: Isabell Remus, Head Biosimilars Western Europe, Sandoz International Table 2 Innovation and Biosimilars Invitation to: Andrea Bean, Director, Biosimilars, Amgen Keynote Address: Research On Early Stage Biologics For Chronic And Inflammatory Conditions Javier Coindreau, Vice President Global Medical Affairs, Biosimilars, Immunology and Oncology, Pfizer Developing Biosimilars And Biobetters Manufacturing and Bio-Analytics Stream Keynote Address: The Important Role Of Biosimilars In Creating Headroom For Innovation Andrea Bean, Director, Biosimilars, Amgen Solution Provider Presentation For sponsorship opportunities please contact sponsorship@oxfordglobal.co.uk Morning Coffee & Poster Presentations, One to One Meetings x2, Poster Presentation Sessions Overcoming Challenges In The Clinical Development Of Biosimilars Facilitating success - case study examples of working with the biosimilars industry The successful network approach - a UK strategy to streamline delivery of biosimilar clinical trials Forward thinking approach - attitudes, appetite and acceptance in the NHS Theo Christie, Business Development and Marketing Manager, NIHR CRN Solution Provider Presentation For sponsorship opportunities please contact sponsorship@oxfordglobal.co.uk Pre-Clinical Trials How Successful Are They In Relation To The Manufacturing Of Biosimilars Rafal Derlacz, Senior Project Manager, Polpharma Solution Provider Presentation Lunch, Poster Presentation Sessions SCIEX

6 5 th Annual Biosimilars & Biobetters Congress Day Two 17 th April Panel Discussion What Is The Future For Biosimilars? Moderator: Michael Bayewitch, Senior Director, Global Search & Evaluation, Biologics, Teva Pharmaceuticals Panellists: Gregory Glover, Attorney at Law, Pharmaceutical Law Group PC Steinar Madsen, Medical Director, Norwegian Medicines Agency Invitation to: Philip Ball, Market Access Manager Biosimilars, Napp Pharmaceuticals John Klimek, Senior Vice President, Standards and Industry IT, National Council for Prescription Drug Programs Analytical Strategies For Biosimilars Case studies will show the importance of orthogonal analytical methods Examples will be presented of analytical approaches for the comparison of biosimilar and originator products regarding: o the chemical and physical properties of the molecule and of all the formulation ingredients; o batch-to-batch variations; o potential aggregation of drug products after mixing with human plasma Tudor Arvinte, Professor, The University of Geneva Biosimilar Cell Line And Process Development Cell line development strategies for the selection of the right clone Process design to match product quality and ensure biosimilarity Orit Aharonovitz, Senior Director, Cell Line & Process Development, Teva Pharmaceutical Industries Afternoon Cofee & Refreshments, Poster Presentation Sessions Development Challenges And Chances Of Specialty Biosimilars Andreas Herrmann, Chief Executive Officer, Baliopharm The Concept Of Establishing Analytical Biosimilarity Overview of the biosimilarity concept applied statistical data evaluation Recent case studies and examples Silke Ruzek, Lab Head Physico-Chemical Characterization, Novartis End of Conference

5th Biennial Biosimilars & Biobetters Congress Conference: 16-17 April 2018, Novotel London West, London, UK www.biosimilars-congress.

7 5th Biennial Biosimilars & Biobetters Congress Conference: April 2018, Novotel London West, London, UK HOW TO REGISTER: FAX your booking form to +44(0) PHONE on +44(0) Delegate Details Registration Fees Please complete fully and clearly. Please photocopy for additional delegates Title: Forename: Surname: Job Title: Company/Organisation: Address: Postcode: Country: Direct Telephone Direct Fax: Mobile: Switchboard: Signature: Date: I would like to attend: (Please tick as appropriate) Industry Delegates (Biopharma, Pharma or Biotech Companies) Congress 899 plus VAT 1 day pass 599 plus VAT Day 1 Day 2 Academic Delegates Congress 520 plus VAT 1 day pass 320 plus VAT Day 1 Day 2 Vendor Delegates (CROs, Consultants, Technology and Service Providers) Congress 1,750 plus VAT 1 day pass 999 plus VAT Day 1 Day 2 Poster Presentation 250 plus VAT PROMOTIONAL LITERATURE DISTRIBUTION Distribution of your company s promotional literature to all conference attendees 999 plus VAT Documentation Terms & Conditions of Booking Agreed Terms between the Organiser (Oxford Global Marketing Ltd) and the Delegate: Delegate Booking Fee The Delegate Booking Fee includes: lunches and refreshments throughout the Congress event, conference presentations, workshop and panel sessions, scheduled one-to-one meetings and networking/social events, conference and speaker notes. Delegates may attend, free of charge, all sessions arranged by the Organiser. An admin surcharge of 50 + VAT will be applied to payments settled following the receipt of an invoice. This charge will not be applied to payments settled online. Vendor Delegates will not be eligible for one to one meetings unless they purchase a sponsorship meetings package. These can only be purchased directly from Oxford Global Marketing Ltd and not via the online booking facility. Poster Presentations Those who have booked a poster presentation at the event must provide the poster title, abstract (200 words or less), principal author, organisation, mailing address, , telephone, fax and additional authors, within a month of registration. All poster spaces will be for A0 (841mm x 1189mm) portrait size. Cancellation and Curtailment Delegates and vendor delegates are subject to the following charges and refunds upon withdrawal or cancellation. More than 6 months prior 35% cancellation fee / 65% refund Between 6 and 3 months prior 75% cancellation fee/ 25% refund Less than 3 months prior to the event Full cancellation fee / No refund Data Protection The data controller is the Organiser. The Organiser may disclose such personal information to Registered Event Sellers (Solution Providers) and other Delegates but solely for the purposes of the Event. The Delegate consents to the use of his/her personal and company information on the terms set out herein. Miscellaneous This Agreement may not be transferred or assigned by either the Delegate or the Delegate s Company. The Organiser will determine the scope and content of Congress conference events, seminars, workshops and activities throughout the Event. The Organiser reserves the right to cancel the Event without liability to Delegate s Company or individual Delegate. If for any reason the Organiser has to cancel or postpone this Event, the Organiser reserves the right to transfer this Booking to another Congress within the same sector to be held within twelve months. Should another Congress in the same sector not be available within this period, the Booking Fee will be refunded. For promotional purposes, there may be professional photography and video production taking place during the conference. Delegates who do not wish to be filmed or recorded should advise the organisers by to operations@oxfordglobal.co.uk, prior to the event I cannot attend but would like to purchase access to the following: Access to the online conference presentations 499 plus VAT VAT is charged at 20% on the attendance fees for all delegates. VAT is also charged on online and paper copy documentation and promotional literature distribution for all UK customers and for those EU customers not supplying a registration number for their own country here. How to Pay (choose one of the following payment options) Number of delegates: Industry del(s) Academic dels(s) Vendor dels(s) Special Offer: 3 for 2 Offer is only valid on the congress and for those registering at Industry or Academic rates CREDIT CARD: Visa MasterCard Maestro Amex Credit Card Number: Valid from: / Expiry Date: / Security code: Cardholders name: Signature: Date: PLEASE INVOICE ME: Invoice Address (if different from above) *Please note there is a 50 plus VAT handling charge for payment via invoice I agree to the above Terms and Conditions If you have any further queries please call the marketing team on +44(0) or marketing@oxfordglobal.co.uk

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