Biosimiler-ek használatának előnyei avagy miért előnyös a verseny? Dr. Szalai Gyula Sandoz Hungária Kft.

A VERSENY HATÁSAI 1 2 3 Rövid távú hatás – Ráfordítások csökkenése Közép távú hatás – Betegek hozzáférése a kezeléshez nő 3 Hosszú távú hatások – Innováció serkentése The presentation is structured in line with the global BU key messages, as outlined on the final slide of the Sandoz Biopharmaceuticals section: Biologic drugs have revolutionized modern medicine and will continue to do so, but patient access is increasingly limited by high costs and growing demand. Access is also an unmet medical need. High-quality, clinically-proven biosimilars, pioneered by Sandoz, are making biologics more affordable. Sandoz is collaborating with governments, payors and health care professionals to maximize access and benefits for patients. Sandoz – a Novartis company – is the world leader in developing, manufacturing and commercializing biosimilars. We are committed to driving the next biologics revolution to transform patient care. The fourth section provides optional back-up material about Sandoz as a company. 2 2 2

1 Rövid távú hatás – RÁFORDÍTÁS CSÖKKENÉS Source: IGES study July 2011 The presentation is structured in line with the global BU key messages, as outlined on the final slide of the Sandoz Biopharmaceuticals section: Biologic drugs have revolutionized modern medicine and will continue to do so, but patient access is increasingly limited by high costs and growing demand. Access is also an unmet medical need. High-quality, clinically-proven biosimilars, pioneered by Sandoz, are making biologics more affordable. Sandoz is collaborating with governments, payors and health care professionals to maximize access and benefits for patients. Sandoz – a Novartis company – is the world leader in developing, manufacturing and commercializing biosimilars. We are committed to driving the next biologics revolution to transform patient care. The fourth section provides optional back-up material about Sandoz as a company. A biosimilerek alacsonyabb ára csökkenti a kiadásokat és gyakran eredményezi az originátor árcsökkenését is 3 3 3 3

1 Rövid távú hatás – RÁFORDÍTÁS CSÖKKENÉS 260 EPO piac Németországban: A Biosimilar piacra lépésének hatása1,2 EUR million 60m EUR megtakarítás az árcsökkenésből This slide, based on a study commissioned by Sandoz from the Berlin-based IGES institute, shows two things: The impact of competition in the first year of epo biosimilar competition in Germany (through end 2008). While initial biosimilar share was low, it led immediately to EUR 20m in direct savings (market entry at a price 1/3 below the originator). The originator reacted by dropping prices by nearly 16%, leading to a further EUR 40m savings. The moral: competition works… The study also predicts potential savings in Germany totaling EUR 8 bn through 2020 (from all biosimilars) if the use of biosimilars is promoted appropriately. Key developments that might prevent these savings being realized were identified as: (a) introduction of reference pricing (b) originators drop prices enough to jeopardize coverage of biosimilar development costs (dumping) (c) originators enter into discount / exclusive supply agreements prior to patent expiry The EUR 25m that are shown in the slide as "additional without restricted access" indicate the potential further savings in the first year of epo biosimilar competition if there had been no anti-competitive practices of the sort outlined above. Piac a biosimilerek előtt Biosimilar árcsök-kentés Originátor árcsök-kentés Piac/ biosimilerek További potenci-ális megtakarítás megszorítások nélkül Potenciális piacméret 1 Source: IGES Institute: The Competitive Role of Biosimilars in the German SHI Market for Pharmaceuticals 2 First 12 months following German market launch in Q4 2007

Ezért fontos a támogatás módja! 260 A biosimilerektől azt várják, hogy 2008 és 2020 között csökkeni fog a biológiai készítményekre fordított kiadás (EU27 adatok) Ezért fontos a támogatás módja! This slide, based on a study commissioned by Sandoz from the Berlin-based IGES institute, shows two things: The impact of competition in the first year of epo biosimilar competition in Germany (through end 2008). While initial biosimilar share was low, it led immediately to EUR 20m in direct savings (market entry at a price 1/3 below the originator). The originator reacted by dropping prices by nearly 16%, leading to a further EUR 40m savings. The moral: competition works… The study also predicts potential savings in Germany totaling EUR 8 bn through 2020 (from all biosimilars) if the use of biosimilars is promoted appropriately. Key developments that might prevent these savings being realized were identified as: (a) introduction of reference pricing (b) originators drop prices enough to jeopardize coverage of biosimilar development costs (dumping) (c) originators enter into discount / exclusive supply agreements prior to patent expiry The EUR 25m that are shown in the slide as "additional without restricted access" indicate the potential further savings in the first year of epo biosimilar competition if there had been no anti-competitive practices of the sort outlined above. Source: IGES study July 2011

260 A megtakarításokat nagymértékben függenek a biosimilerek által elért piaci részesedéstől (EU27 adatok) This slide, based on a study commissioned by Sandoz from the Berlin-based IGES institute, shows two things: The impact of competition in the first year of epo biosimilar competition in Germany (through end 2008). While initial biosimilar share was low, it led immediately to EUR 20m in direct savings (market entry at a price 1/3 below the originator). The originator reacted by dropping prices by nearly 16%, leading to a further EUR 40m savings. The moral: competition works… The study also predicts potential savings in Germany totaling EUR 8 bn through 2020 (from all biosimilars) if the use of biosimilars is promoted appropriately. Key developments that might prevent these savings being realized were identified as: (a) introduction of reference pricing (b) originators drop prices enough to jeopardize coverage of biosimilar development costs (dumping) (c) originators enter into discount / exclusive supply agreements prior to patent expiry The EUR 25m that are shown in the slide as "additional without restricted access" indicate the potential further savings in the first year of epo biosimilar competition if there had been no anti-competitive practices of the sort outlined above. Source: IGES study July 2011

2 Közép távú hatás – Betegek hozzáférése a kezeléshez nő GCSF - UK: Az alacsonyabb költségű biosimilerek szélesebb betegkör számára tették elérhetővé a kezelést United Kingdom Az alacsonyabb biosimilar költségnek köszönhetően sok orvos kezdte a G-CSF kezelést az elsővonalú kemoterápiás kezeléseknél alkalmazni G-CSF csökkenti az infekció okozta a kórházi kezelések időtartamát A biosimilerek ~50% alacsonyabb árúak az originátornál 2008 nov. engedélyezték a biosimilart 2007 2008 2009 2010 UK G-CSF volumen növekedése %-os változás vs. előző év SOURCE: IMS, NHS 7

2 Közép távú hatás – Betegek hozzáférése a kezeléshez nő 7 2 Közép távú hatás – Betegek hozzáférése a kezeléshez nő GCSF - Svédország: A biosimiler vezető piaci részesedést szerzett, miközben a betegek ellátása bővült Összes filgrastim (db) 5 7 8 20 32 32 36 41 43 48 79 90 87 86 82 83 77 70 92 73 95 94 100 100 100 99 99 66 48 56 46 45 41 37 21 24 18 17 19 19 20 15 18 15 16 1 1 5 10 6 13 14 14 8 12 Jan 09 July 09 Jan 10 July 10 Dec 10 Svéd GCSF piaci részesedés A teljes piac százalékában Source: IMS

3 Hosszú távú hatások – Innováció serkentése Lehetőség új terápiák támogatásba fogadására (300 újabb bio molekula érkezik) Innováció Az originátoroknak ésszerű nyereséget kell realizálniuk és a befektetésük megtérülése a cél A szabályozatlan monopóliumok stagnáláshoz vezetnek A biosimilerek a versenyt növelik és erősítik a biológiai innováció “következő hullámát” Biosimilerek This slide summarizes the arguments on previous pages. It reflects the “Novartis philosophy“ referred to in previous presentations, namely that biosimilars and originator biologics are complementary, in the same way as generics and their reference products (saving money both directly and by freeing up funds for further innovation). Verseny Valódi verseny – növekvő innovációt eredményez “azonos szintű pályán” az összes biológiai készítmény számára 9 9