The generics environment today Sergio Napolitano EGA Director Legal Affairs and Trade 2 October 2015, Warsaw
C O M PA N I E S N AT I O N A L A S S O C I AT I O N S EGA Membership GE (Hungary) SPMA (Slovenia) 2
C O M PA N I E S N AT I O N A L A S S O C I AT I O N S EBG Membership 3
EGA Vision 2020 To provide sustainable access to high quality medicines for all European patients 4
EGA Vision 2020 5
Evolution of EGA Structure 6
Europe: a global hub for high-quality generic and biosimilar medicines European Countries with generic medicines R&D and manufacturing* European Countries with manufacturing sites of EU approved biosimilars**, under development and under evaluation* Source: *EGA Internal data - **EMA EPARs 7
Generic Medicines 8
Generic medicines A cornerstone of healthcare sustainability Without generic medicines drug bills would be 40 BN more in the EU One of the Most Competitive More than Sectors in 350 manufacturing sites Europe employing over Generic medicines account for 55% 21% of dispensed medicines of pharmaceutical expenditure 7% of turnover to R&D exporting to more than 160,000 European citizens 100 countries outside the EU 9
Benefits of generic competition in the off-patent sector GENERIC COMPETITION Widely used well-established medicines LOWER COST Price competition or payer driven price reduction mechanisms INCREASED PATIENT CHOICE Competition increases available presentations of a product MORE ACCESS TO MEDICINES More patients treated for less money. ENABLES INNOVATION Enables reimbursement of innovative and value-added medicines 10
Generic medicines enhance access to medicines, reducing inequalities, directly leading to improved patient outcomes Hypertension treatment EU 28 (2013) Diabetes treatment EU 28 (2013) 82 million treated patients 48 million treated by generic medicines 59% generic medicines share 36 million treated patients 20 million treated by generic medicines 54% generic medicines share Source: Euro Barometer; BMC Public Health Internal estimate based on IMS MIDAS 11
In chronic disease areas, patient access to treatment has doubled, while spending remains flat Last 10 years (2005 2014): >100% increase in prescription volumes >50% decrease in price of medication per treatment day Evolution in seven therapy areas Selected therapy areas: angiotensin II antagonists, anti-epileptics, antipsychotics, anti-ulcerants, cholesterol regulators and oral anti-diabetics. Use of generic medicines post-patent expiry acts as a balance for the expenditure of new products 12
Ageing population: Major EU social and economic challenge Ageing population and poor lifestyle will increase demand for medical services and pharmaceuticals Europe ageing population forecast to 2050 Selected therapy areas: angiotensin II antagonists, anti-eipleptics, anti-psychotics, anti-ulcerants, cholesterol regulators and oral anti-diabtetics. 13
Usage of generic medicines has increased Generic medicines market share by volume (2001-2012) 100% 90% 80% 70% 60% 50% 40% 30% 31% 33% 35% 37% 39% CAGR: +5% 41% 43% 44% 46% 47% 49% 51% 20% 10% 0% Source: IMS MIDAS Market Segmentation Data 12 Months to 2012 (2012) 14
But still room for increased generic penetration to further increase access for patients Generic medicines market share by volume (June 2014, total Rx retail market) 80.0% 70.0% 72.9% 68.9% 66.0% 65.6% 60.0% 60.0% 57.0% 55.6% 55.0% 54.8% 50.0% 40.0% 52.5% 52.3% 51.3% 49.9% 49.1% 47.8% 44.3% 43.5% 40.6% 38.8% 37.5% ~3x 30.0% 27.3% 20.0% 10.0% 0.0% Need to introduce demand-side policies to maximize savings and foster a competitive and sustainable supply Source: IMS MIDAS mat June 2014, Rx Retail market 15
Sustainable pricing policies A focus on cost-containment leads to: Decreased competition & increased costs Concentration of suppliers & shortages Decreased patient access Europe must set long-term, sustainable pricing policies to guarantee supply Demand side policies targeting patients, pharmacists, physicians Supply side policies which avoid short-term cost-containment measures 16
Biosimilar Medicines 17
Biosimilar medicines: Key facts 18
Biosimilar medicines: Key facts +55% of biosimilar medicines used worldwide are produced in Europe 2007-2020 :Cumulative savings for 8 EU Countries up to 33.4 b * By 2018, half of pharmaceutical expenditure will come from biologicals** Strong R&D investment in Europe - biosimilar medicines present in 14 member states Since 2006, EU approved biosimilar medicines have generated more than 400 million patients days of clinical experience worldwide*** Source: * IGES study - **Prime Therapeutics & University of Minnesota College of Pharmacy, poster presented at AMCP San Diego April, ***EGA internal data 19
The increase in Biosimilar medicines use 20
Biosimilar medicines increase patient access Biosimilar filgrastim: 30% more patient access to gold standard earlier in Europe Biosimilar Filgrastim : 72% of volume, more than 10% increase in patient access Biosimilar Filgrastim : 83% volume, 44% increase in patient access 21
A sustainable national policy framework should cover: 1. Education and information 2. Incentivisation of appropriate early use 3. Collection of Real World Evidence (RWE) 4. Transparent and evolutionary procurement 22
Value Added Medicines 23
What is a Value Added Medicine? Known molecules which deliver significant improvements and address unmet needs for: Patients, payers and/or health care professionals Added value may be created thanks to: Better health outcomes Quality of life Improved tolerability Better adherence Less dosing frequency Reduction of medical errors Any other innovative solution 24
Value added medicines are different to generic medicines Considerable time & costs associated with R&D Costs 100x higher than standard generics Regulatory uncertainty No guarantee of market exclusivity Higher commercialisation risk Larger Sales & Marketing investments (e.g. HCP training) Slower uptake 25
Value Added Medicines: An Opportunity for Europe Example: Pre-filled Syringes Convenient System Reduced re-constitution steps Ready To Use, Economical Reduced risk of contamination Safer working environment Reduced risk of needle stick injuries with Leur-Lock systems Reduced risk of errors / mix-up of reconstituted medicines. Ideal platform for emergency medicine in OT settings Example: Inhalers asthma & COPD Adherence rates are lower than other chronic conditions 1 Total annual cost of unscheduled events due to poor inhalation technique: 18.8 million/year 2 1 Hansen R et al. Transplant Proc 2007;39(5):1287 1300 2 Lewis A et al. Poster (36700) presented at The International Society For Pharmacoeconomics and Outcomes Research (ISPOR) 19th Annual International Meeting in Montreal, QC, Canada, 31 May 4 June 2014 26
EGA - Legal Affairs 27
The work on trademarks Double dimension: public health & IP Quality EGA engagement on counterfeit medicines Active role with EU institutions 28
The EGA in the international arena 29
International cooperation IGBA International Generic and Biosimilar Medicines Association EU, US, Canada, Japan, Jordan, South Africa, Taiwan, Mexico, Australia, Brazil Fostering International Trade in Generic and Biosimilar Medicines Cooperation with all international institutions (WHO, WTO, WIPO, ICH ) Dialogue with IFPMA 30
Regulatory cooperation International regulatory cooperation EU-US Transatlantic Trade & Investment Partnership (TTIP) Mutual recognition of GMP inspections Single EU-US development for biosimilars & complex generics 31
Questions? Sergio Napolitano EGA Director Legal Affairs and Trade sergio@egagenerics.com 32