Biosimilars are interchangeable with their reference products under the supervision of a health care person.

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1 EXTENDING THE USE OF BIOSIMILAR DRUGS: ARE WE WILLING TO ACCEPT THE UNCERTAINTY RELATED TO SWITCHING IN ORDER TO IMPROVE PATIENT ACCESS TO MODERN MEDICINES? Tomas Tesar, PharmD, PhD, MBA, MSc Member of the Reimbursement Committee of the Slovak MoH on behalf of Union Health Insurance Fund, Bratislava, Slovakia Position: Biosimilars are interchangeable with their reference products under the supervision of a health care person. Uncontrolled exchange between biologicals (whether originators or biosimilars) must be avoided. A patient must receive adequate clinical monitoring and clear instructions. New patients can be treated with a biosimilar right away. 1

2 In 2013, a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars. ECCO survey 2015 vs Little or no confidence in using biosimilars 63% 19,5% Interchangeability 6% 44,4% Should carry distinct INN 66% 35% Main concern: immunogenicity 69% 69% Switches between biological products are common and usually not problematic, e.g. in the context of hospital tendering processes. Risk of adverse effects can be expected to be similar to the risk associated with changes in the manufacturing process of any biological products. 2

3 Competition drives down the price Epoetin (EPO) TOTAL MARKET Portugal -61% Slovakia -52% Poland -49 % Granulocyte colonystimulating factor (G-CSF) Slovakia -59% Bulgaria -58% Slovenia -50 % TOTAL MARKET Competition drives down the price Human growth hormone (HGH) Finland -47% Poland -47% Slovakia -31 % Anti-tumor necrosis factor (Anti-TNF) Sweden -21% Bulgaria -19% Denmark -15 % TOTAL MARKET TOTAL MARKET 3

4 Lower prices increase patient access in countries with low initial usage Epoetin (EPO) Romania -36% 460% Bulgaria -46% 120% Poland -49% 186% Human growth hormone (HGH) Romania -27% 177% Czech Rep. -20% 54% Poland -47% 78% Granulocyte colonystimulating factor (G-CSF) Lower prices increase patient access in countries with low initial usage Romania -48% 498% Bulgaria -58% 1016% Slovakia -59% 371% Anti-tumor necrosis factor (Anti-TNF) Bulgaria -19% 131% Czech Rep. -12% 53% Slovakia -8% 78% 4

5 A sustainable biosimilar market Payers claim: A sustainable biosimilar market is a market in which biosimilars create financial savings without jeopardizing the current treatment standards. Biosimilar manufacturers claim: A sustainable biosimilar market is a predictable market supporting the co-existence of biosimilar manufacturers and a price-volume combination that enables continuous investment in further innovation. Source: Simon-Kucher & Partners; Payers price & market access policies supporting a sustainable biosimilar medicines market Criteria designed to reflect how both payers and manufacturers view the ideal sustainable biosimilar medicines market: High biosimilar share Payer guidance on biosimilars vs. originators Fair price level for biosimilar Commercial attractiveness Acknowledgement of high complexity of biologics within P&MA process Maintaining healthy competition in the long-term Low effort needed to monitor and enforce policy Parallel sourcing from multiple manufacturers Earlier and broader use of biosimilar in additional patient segments Source: Simon-Kucher & Partners; Payers price & market access policies supporting a sustainable biosimilar medicines market 5

6 A sustainable biosimilar medicines market is one that provides continued benefits to all stakeholders: increased access for patients, more treatment options for physicians, sustainability healthcare budgets for payers, business opportunities for manufacturers. IMS estimated cumulative savings in EU5 and the US around 50 billion euros to 100 billion euros over the next five years. (8 key products losing exclusivity protection in for price reduction between 20 and 40%) 6

7 Thank you for your attention 7