IS BIOSIMILARS COMPETITIVE INTELLIGENCE DIFFERENT?

IS BIOSIMILARS COMPETITIVE INTELLIGENCE DIFFERENT? Duncan Emerton Senior Director, Syndicated Insights & Analysis FirstView (a division of FirstWord Pharma) T: +44 7964 920415 E: duncan.emerton@firstwordgroup.com Pharma CI USA September 9-10, 2014 Hilton Parsippany Hotel, NJ

AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 2

AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 3

INTRODUCTIONS Copyright and Disclaimer Copyright 2014 Doctor s Guide Publishing Limited. All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher The content and views in this presentation are the views of the author and do not reflect the views of P/S/L Group s.a.r.l, FirstWord Pharma or FirstView. P/S/L Group s.a.r.l, First Word Pharma, FirstView and the author make no representations regarding the accuracy or completeness of the data presented or data used from referenced sources While the facts in this slide pack are believed to be correct at the time of publication, they cannot guaranteed. The facts in this slide pack are also a summary of key events, and must not be considered an exhaustive analysis of the biosimilars market The author, P/S/L Group s.a.r.l, FirstWord Pharma and FirstView can accept no liability whatsoever for actions taken based on any information that may subsequently prove to be incorrect Sources: FirstView 4

INTRODUCTIONS What qualifies me to talk about CI in the biosimilars market? Extensive industry experience, focused on biosimilars since 2006 (the year the first biosimilar was approved) Previous roles include R&D, sales, marketing, medical affairs, business analysis and strategic consulting Spent 9 years at Datamonitor, final role was Director and Biosimilars Practice Lead within the healthcare consulting team Primarily focused on supporting CI, BD&L and brand strategy functions; have worked with originators and biosimilar developers (but never at the same time) Published/quoted on the subject of biosimilars, regular presenter and Chair at biosimilar conferences Editor-in-Chief, The Biosimilarz Blog! (www.biosimilarz.com) Sources: FirstView 5

INTRODUCTIONS Sources of data and insight (1) Semi-structured interviews (approximately 30 mins) with three (3) competitive intelligence professionals focused purely on biosimilars Combined CI experience of over 30 years, currently working for an originator (n=1; EU based, global role) and biosimilar developer (n=2; both EU based, primarily focused on Europe and emerging markets) Key areas of focus during discussions included perceived differences between biosimilars CI and other forms of CI (e.g. branded, novel product, generics), key challenges and critical success factors Sources: FirstView 6

INTRODUCTIONS Sources of data and insight (2) Biosimilar Index: Tracking the Biosimilar Development Landscape The Future of Biosimilars: Mapping Critical Uncertainties and the Impact of Future Events Biosimilars in Emerging Markets: Expert Insights and Critical Success Factors for Future Success Sources: FirstView 7

AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 8

A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other ~40 key biosimilar clinical trials initiated since the beginning of 2013 (e.g. mabs, insulin, fusion proteins) in multiple indications and multiple countries How and where are we/they sourcing the reference product? What study design are we/they using; endpoints, patients, dosing, indications? What regulatory guidelines are being used? Local requirements? Which products should we be following? (Direct and Indirect competition) Data presentations at key therapy area conferences (e.g. ASCO, ACR, EULAR, ASD) How biosimilar are these products compared to our brand and/or biosimilar? What impact could this data have on our clinical and regulatory strategy? How likely is extrapolation to other indications based on this data? Too early? Sources: FirstView s Biosimilar Index (September 2014) 9

A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other New guidelines are emerging, old guidelines and being updated and controversies continue to appear How will new guidelines impact my current and future development strategy? (FDA) What regulatory changes can we expect in emerging markets? (BRICMAT) Which guidelines with EMA update next, and will this affect me? When can we expect interchangeability guidance, what will it include? (FDA) Submissions and approvals; multiple countries, multiple products, multiple indications maybe? What analogues can I use for submission/review timelines? (US vs. EU vs. JP vs. RoW) Which biosimilar programmes against my company s product will submit next? What s the expected impact of national position statements on biosimilar use? (Italy/UK) How will differing approaches to extrapolation influence other agencies? (Canada) Sources: FirstView s Biosimilar Index (September 2014) 10

A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other Over 60 new biosimilar focused deals and alliances have been forged since the start of 2010 1 What do these deals and alliances mean? How much of an impact will deals in emerging markets affect global strategy? Do I only need to focus on the ones involving Big Biopharma, or everything? What do the affiliates think? Market value remains a hotly debated topic, with the value of the market forecast to reach between $4-$200 billion by 2020! What analogues and proxies can we use to assess up take and impact? Does the evolution of the generics market provide any meaningful guidance? What advice can I provide my PR&MA colleagues? What can they tell me? Which market scenario should we adopt as a our base case? Sources: FirstView s Biosimilar Index (September 2014); (1) The Biosimilarz Blog (here) 11

A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other Challenges to IP begin to gain importance How robust is our IP strategy for our branded biologic? Is there any way that we can extend our IP position? Do we need to? What tactics can we use to challenge the IP of the product we are targeting? What about device patents? How do we defend/attack these? Do we need to focus on IP when it comes to brand defense? How can we use regulations and claims of biosimilarity in each of the markets to defend our market share? (Roche) Sources: FirstView s Biosimilar Index (September 2014) 12

A (VERY) QUICK REVIEW OF WHAT S BEEN HAPPENING Key events, key questions Clinical Regulatory Commercial Legal Other Policy changes at the national and state level What could be the impact of France s stance on automatic substitution? How will each state handle substitution laws in the US? (Lobbying) Will different INNs make any difference to the market s evolution? (US, WHO) Stakeholder awareness and understanding of biosimilars back in the spotlight Do key stakeholders know enough about biosimilars? What efforts must we exert to improve knowledge and understanding? What does our educational strategy need to include? Sources: FirstView s Biosimilar Index (September 2014) 13

THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries mabs the dominant class (excludes fusion proteins) due to the perceived commercial opportunities Filgrastim and EPO-alfa the most common target, with rituximab the most popular mab target for biosimilar developers Cancer, rheumatology and diabetes are the dominant therapy areas for biosimilar developers Mix of companies is diverse, including many big players! Sources: FirstView s Biosimilar Index (September 2014) 14

THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries mabs the dominant class (excludes fusion proteins) due to the perceived commercial opportunities Filgrastim and EPO-alfa the most common target, with rituximab the most popular mab target for biosimilar developers Cancer, rheumatology and diabetes are the dominant therapy areas for biosimilar developers Mix of companies is diverse, including many big players! Sources: FirstView s Biosimilar Index (September 2014) 15

THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries mabs the dominant class (excludes fusion proteins) due to the perceived commercial opportunities Filgrastim and EPO-alfa the most common target, with rituximab the most popular mab target for biosimilar developers Cancer, rheumatology and diabetes are the dominant therapy areas for biosimilar developers Mix of companies is diverse, including many big players! Sources: FirstView s Biosimilar Index (September 2014) 16

THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries mabs the dominant class (excludes fusion proteins) due to the perceived commercial opportunities Filgrastim and EPO-alfa the most common target, with rituximab the most popular mab target for biosimilar developers Cancer, rheumatology and diabetes are the dominant therapy areas for biosimilar developers Mix of companies is diverse, including many big players! Sources: FirstView s Biosimilar Index (September 2014) 17

THE CURRENT STATUS OF THE MARKET Which molecules, companies, markets and diseases? Class Molecule Indications Companies Countries Sources: FirstView s Biosimilar Index (September 2014) 18

KEY TAKEAWAY Diversity, complexity, uncertainty Sources: FirstView s Future of Biosimilars (May 2014) 19

AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 20

CHALLENGES IN BIOSIMILARS CI Or how to keep multiple plates spinning at the same time Sources: FirstView 21

CHALLENGES IN BIOSIMILARS CI Key productivity pirates Information Forecasting Speed Markets Agony Aunt Uncertainty Sources: FirstView 22

AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 23

CRITICAL SUCCESS FACTORS What do the CI professionals think? INFORMATION & INSIGHT Work hard for your information; if you don t know, find out Focus on data and insight quality, especially in emerging markets Balance global vs. local insight it s not just about the 7MM PROCESSESS Make sure your reporting processes are robust and engaging, and seek feedback Do as much as you can to automate what you do, so you can focus on interpreting the meaning and implications Critical Success Factors RELATIONSHIPS Build an experienced support team, including internal and external people Strive for strong internal support and understanding of biosimilars CI Get to know your brand teams and your affiliates! PERSONAL Be able to say no when you don t have time, and give good reasons Be comfortable with uncertainty, and be able to instil this comfort others Sources: FirstView 24

AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 25

IS BIOSIMILARS CI DIFFERENT? In my opinion, biosimilars competitive intelligence is unique. There is a need to understand multiple issues, from manufacturing, clinical trials, IP, regulatory issues, device technology, to name a few. You also need to be knowledgeable on several therapy areas. Compared to innovative product CI, the competitive landscape is deeper, wider and broader YES 26

AGENDA INTRODUCTIONS KEY DYNAMICS AND MARKET SNAPSHOT... KEY CHALLENGES IN BIOSIMILARS CI CRITICAL SUCCESS FACTORS IN BIOSIMILARS CI... IS BIOSIMILARS CI DIFFERENT...? THANK YOUS AND Q&A... 27

QUESTIONS, COMMENTS, HECKLING? duncan.emerton@firstwordgroup.com uk.linkedin.com/in/duncanemerton @fwpharma @biosimilarz www.fwreports.com www.biosimilarz.com 28