+50% Market share for biosimilar G-CSF 2

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1 The Biosimilar Market Leader s Perspective Carol Lynch, Global Head of Sandoz Biopharmaceuticals April 28, years on, biosimilars have had a strong impact on global healthcare Product Approvals 20+ Products approved by the European Medicines Agency over 10 years 1 Market Acceptance +50% Market share for biosimilar G-CSF 2 Patient Experience +250m Patient days of safe clinical experience with Sandoz biosimilars alone 3 Healthcare system savings 551M Estimated cumulative savings from biosimilars epoetins in Germany Increased patient access 10 Increase in standard units of filgrastim in the UK from (post biosimilar launch) 5 1. European Medicines Agency Website 2. IMS MIDAS 3. Sandoz Product Safety Update Report (accessed October 2015) 4. IMS Institute for Healthcare Informatics: Assessing biosimilar uptake and competition in European markets. Date of Report: Oct IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar Medicines for Europe Biosimilars Conference April 2016

2 However, the status quo must change for biosimilars to deliver on its promise Critical Challenges Strategic Imperatives 1. Stakeholder understanding and acceptance Build Trust & Confidence 2. Disproportionate focus on acquisition costs Ensure Sustainable Market Policies 3. Continued legal and regulatory uncertainties (mainly in US) Clarify Legal and Regulatory Uncertainties 3 Medicines for Europe Biosimilars Conference April 2016 Recent US and EU biosimilar launches indicate progress in building stakeholder acceptance... Filgrastim US 25 Infliximab EU5 Pre-launch educational efforts across stakeholders helped address key concerns 20 17% 17% 2 Physicians accept biosimilar concept in acute care settings Economic value recognized by payors & healthcare providers Prescriptions (in %) % 0 Jan-15 Feb-15 MAR/15 1 9% 3% Apr-15 MAY/15 15% 5% 2% Jun-15 Source: IMS Pharmascope 1 Community medical center: MVZ in Germany, therefore, possible multiple specialties are included 4 Medicines for Europe Biosimilars Conference April 2016 Gastro Rheuma Derma GPs/community medical centers Others Total Biosimilar penetration

3 ...However, all stakeholders must contribute to improving trust and confidence in biosimilars Regulators: Engage with HCPs on robustness of regulations/extrapolation Payors: Support biosimilar education amongst HCPs HCPs: Deepen understanding of biosimilars and help reassure patients Increasing adoption of biosimilars Patient Groups: Develop and share educational content for patients Govt: Continue to highlight societal value of biosimilars across stakeholders Manufacturers: Ensure availability of science-based information on biosimilars Collectively address the scourge of misinformation 5 Medicines for Europe Biosimilars Conference April 2016 Considerable variation across the EU exists in terms of payer policy approaches to biosimilars Most patients out of reach for manufacturers Competition averse Foster competition Many patients available for manufacturers to compete for National management passive (i.e. fixed biosimilar price reduction) No prescribing incentives No prescription quota Increased active management nationally Education of physicians by payers Biosimilar prescribing stimulated (quotas) Source: Adapted from IMS Health, IMS Consulting Group, March Medicines for Europe Biosimilars Conference April 2016

4 Healthcare systems must advance policies that ensure sustainability Sustainable Procurement No winner takes all tenders Acknowledge that biosimilars are not generics: no mandatory price cuts Promote fair competition and levelplaying field Prescribing Incentives Gain-sharing that helps hospitals to benefit from savings Quotas to create competition while retaining prescriber choice Support acquisition of most cost-effective medication by hospitals 7 Medicines for Europe Biosimilars Conference April 2016 Legal and regulatory clarity essential for further development of the biosimilars industry BPCIA Ambiguities INN & Labeling Interchangeability Maintain established regulatory framework 8 Medicines for Europe Biosimilars Conference April 2016

5 Collectively, we can ensure biosimilars play an even more transformational role in global healthcare Generate savings for healthcare systems Improve patient access 49-98B Expected cumulative savings from biosimilars in US+EU5 1 ~5% Patients with moderate-to-severe psoriasis receiving biologic medicines 2 1. IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar Ref: Nast A, et al. Arch Dermatol Res 2013;305(10): Medicines for Europe Biosimilars Conference April 2016

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