1. Improving access to generic & biosimilar medicines in Bulgaria and in the EU 1 Adrian van den Hoven Director General EGA – European Generic medicines Associations Sófia, 14 th November 2013

2. Patient access to high-quality medicines Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Executive summary 2 Conclusion The healthcare environment

3. The European Generic Medicines and Biosimilar Medicines Association (EGA) is at the heart of Europe’s medicine industry and is essential to EU Public Health. 1 Patients 2 5 4 3 Quality Value Sustainability Partnership

4. Generic medicines bring savings of 35€ Bn p.a. in the EU 28 Generic medicines account for almost 54% More than 1000 generic companies directly employing 150,000 European citizens One of the most competitive sectors in Europe volume 7% of turnover to R&D exporting to more than 100 countries outside the EU value 21% The EU generic medicines industry is highly committed to Europe’s health 4

5. 7 key therapy areas: 60% price decrease/ 200% increase in number of treatment days © 2013, IMS HEALTH Selected therapy areas: Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholestrol regulators and oral anti-diabetics. Source: IMS MIDAS, MAT 09 2012

6. Generics provide increased access to affordable medicines 6 © 2013, IMS HEALTH Selected therapy areas: Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholestrol regulators and oral anti-diabetics. Source: IMS MIDAS, MAT 09 2012

7. Projection for EU28, 2013 ATC classes: A10 drugs used in diabetes Generic share: 54% Total number of treated patients: 36 million Patients treated by generic medicine: 20 million Source: International Diabetes Federation (IDF), Diabetes Atlas; European Community Health Indicators (ECHI) Internal estimate based on IMS MIDAS Prevalence: 8.5%, adult population aged above 15 years Diabetes patients treated in Europe 7

8. Projection for EU28, 2013 ATC classes: C2 antihypertensives Generic share: 59% Total number of treated patients: 82 million Patients treated by generic medicine: 48 million Prevalence: total hypertension 40% of population aged above 15 years; 19% - treated hypertension, Hypertension patients treated in Europe 8 Source: Euro Barometer; BMC Public Health - Internal estimate based on IMS MIDAS

9. Generic Medicines generate savings 9 Source: European Commission and Mrazek & Frank, 2004 in WHO - Health policy responses to the financial crisis in Europe report). “(… )policies promoting the use of generic medicines are often at the forefront in the attempt to increase the cost-effectiveness of medicinal products”. EC-FIN “Policies to promote greater use of generic medicines are likely to lower pharmaceutical expenditure and enhance efficiency” –WHO Report

10. Lipitor generics help NHS save £1m per day (in the UK), Pharma Times, 15 May The NHS saved more than £350 million in the first 12 months after the patent expiration of Pfizer’s Lipitor last year. (…), now costs just £1.89 – the price tag for Lipitor comes in at £13 for the same pack size and dose, according to the British National Formulary. 10

11. Patient access to high-quality medicines Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Executive summary 11 Conclusion The healthcare environment

12. Avg. EU-27 health exp. Growth rates from 2000 to 2011, public and total 12 Source: OECD, 2013 In 2010, health spending fell in Europe for the first time since 1975

13. Health expenditure by function of care, OECD avg., annual growth 13 Source: OECD, 2013 Pharmaceutical sector cuts

14. Disruptive change :unsustainable market environment National +EU levelNational level Generic and biosimilars medicines Pharmaco- vigilance Legislation Availability of medicines Falsified Medicines Directive Clinical Trials Regulation Variations Regulation Well-intended EU legislation complexity and cost External reference pricing Discounts/rebates, payback and clawback policies Price freezes and price cuts Retail tendering Governments take short- term cost measures 14

15. Patient access to high-quality medicines Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Executive summary 15 Conclusion The healthcare environment

16. Making the Generic medicines market grow 16 Increase doctors prescription of Gx Therapeutic guidelines E- prescription systems Prescription budget Prescription quotas Increase savings for the Bulgarian health system

17. Making the Generic medicines market grow 17 Increase savings for the Bulgarian Health system Remuneration scheme that incentivises the dispensing of the lower price medicines Establish remuneration linked to the level of achievement of a substitution goal Incentives for pharmacies to dispense generic medicines

18. External Reference Pricing Not for generics Key risks when introducing ERP: 1.Generic medicines prices below profitability level 2.Artificial downward price spiral (procurement and tendering) 3.Price linkage – ERP is applied twice 4.Inability to launch generics in some markets 5.Divergences in updating price lists WHO : ERP not appropriate for generics 18

19. Patient access to high-quality medicines Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Executive summary 19 Conclusion The healthcare environment

20. Cumulative savings for 8 EU countries, 2007-2020: between €11.8 up to 33.4 b€ 1 Emerging markets for biologic medicines represent $15Bn opportunity Specialty drugs are forecasted to be 50% of all drug expenditure in 2018 2 Biosimilar Filgrastim increased patient access by 44% in the UK 3 Biosimilar medicines as a major opportunity for EU European biosimilar medicines industry needs strong support to develop 20 Source: 1. IGES study – 2. Prime Therapeutics & University of Minnesota College of Pharmacy, poster presented at AMCP San Diego April 4 - 3: UK Filgrastim Volume (in Std. Units) increased by 44% between 2009 and 2012

21. Adoption of biosimilars has increased access and generated savings in the major EU countries Estimates put annual savings in excess of €120 million in these countries Total 10 countries 443M $ MAT 03/2013 Fast uptake at launch, now mature Consistent uptake Cultural resistance but change undergoing Fast growing due to market trends Biosimilar replaced originator supply Source: IMS MIDAS, MAT 03/2013 © 2013, IMS HEALTH Generic medicines and biosimilars generating savings beyond the medicines bill 21

22. Future biosimilars offer more saving among newer therapies: anti-TNF and Mabs Source: IMS MIDAS, Mar 2013 Existing (It includes old generation insulins which are unlikely to be targeted by biosimilar players) EU approved © 2013, IMS HEALTH Generic medicines and biosimilars generating savings beyond the medicines bill 22

23. Biosimilars and the way ahead Information for doctors : Clear, unbiased information on the scientific concept of biosimilars, approval process, safety and efficacy Member States: Guidelines to incentivize physicians to prescribe biosimilars; reimbursement rules for biosimilars uptake Reimbursement: remove hurdles or delays to pricing and reimbursement approval to increase savings and patient access Advanced Manufacturing Rule: allow European based industry to compete early in emerging markets; Bulgaria 10 % of EU manufacturing

24. Patient access to high-quality medicines Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Executive summary 24 Conclusion The healthcare environment

25. European countries with generic medicines R&D and manufacturing* European countries with generic medicines manufacturing* European Countries with manufacturing sites of EU approved biosimilars** Europe is the global hub for high-quality generic and biosimilar medicines 25 Source: *EGA Internal survey - **EMA

26. Industrial Policy Emerging market opportunities 26 Emerging markets : 18% to 28% of the global medicines market from 2010- 2015 Source: IMS Health 2011

27. Market Loss of EU Generic and Biosimilar Medicines Industry Period of market loss to EU companies Date of international competition 20 year patent + Up to 5 year SPC

28. Patient access to high-quality medicines Supporting the Generic medicines market Savings through the use of Biosimilar medicines Boosting Manufacturing Executive summary 28 Conclusion The healthcare environment

29. Generic and biosmilars Medicines Industry EU and Member States authorities Jobs and Growth Generate savings Increase patient access Stronger collaboration is needed to foster industry and to compete at global level 29

30. It is time to support the generic and biosimilar medicines industries Conclusion Medicines provide huge value to patients and healthcare systems Stability of pricing for generic and biosimilar medicines is needed Well thought out regulations that achieve patient safety and reduce complexity are key 30

31. благодаря 31 Adrian@egagenerics.com