Sergio Napolitano EGA Director Legal Affairs and Trade · Example: Inhalers – asthma & COPD...

The generics environment today Sergio Napolitano

EGA Director Legal Affairs and Trade

2 October 2015, Warsaw

EGA Membership

SPMA

(Slovenia)

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GE

(Hungary)

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EBG Membership C

OM

PA

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EGA Vision 2020

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To provide sustainable access to high quality

medicines for all European patients

EGA Vision 2020

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Evolution of EGA Structure

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Europe: a global hub for high-quality

generic and biosimilar medicines

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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

Generic Medicines

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Generic medicines – A cornerstone

of healthcare sustainability

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Without generic medicines

drug bills would be

€40 BN more in the EU

More than

350 manufacturing sites

employing over

160,000 European citizens

Generic medicines account for

55% 21% of dispensed of pharmaceutical

medicines expenditure

7% of turnover to

R&D

exporting to more than

100 countries outside the EU

One of the

Most

Competitive

Sectors in

Europe

Benefits of generic competition in

the off-patent sector

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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

Generic medicines enhance access to medicines,

reducing inequalities, directly leading to

improved patient outcomes

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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

In chronic disease areas, patient access to

treatment has doubled, while spending remains flat

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Evolution in seven therapy areas

Last 10 years (2005 – 2014):

>100% increase in prescription volumes

>50% decrease in price of medication per treatment day

Selected therapy areas: angiotensin II antagonists, anti-epileptics, anti-psychotics, 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

Ageing population: Major EU social

and economic challenge

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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.

Usage of generic medicines has increased…

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31% 33%

35% 37%

39% 41%

43% 44% 46% 47%

49% 51%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

CAGR: +5%

Generic medicines market share by volume (2001-2012)

Source: IMS MIDAS Market Segmentation Data 12 Months to 2012 (2012)

But still room for increased generic penetration to

further increase access for patients

72.9% 68.9%

66.0% 65.6%

60.0% 57.0% 55.6% 55.0% 54.8%

52.5% 52.3% 51.3% 49.9% 49.1% 47.8% 44.3% 43.5%

40.6% 38.8% 37.5%

27.3%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

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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

Generic medicines market share by volume (June 2014, total Rx retail market)

~3x

Sustainable pricing policies

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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

Biosimilar Medicines

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Biosimilar medicines: Key facts

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Biosimilar medicines: Key facts

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+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

Source: * IGES study - **Prime Therapeutics & University of Minnesota College of

Pharmacy, poster presented at AMCP San Diego April, ***EGA internal data

Since 2006, EU approved biosimilar medicines

have generated more than 400 million patients

days of clinical experience worldwide***

The increase in Biosimilar

medicines’ use

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Biosimilar medicines increase

patient access

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Biosimilar Filgrastim : 72% of volume, more than 10% increase in patient access

Biosimilar filgrastim: 30% more patient access to “gold standard” earlier in Europe

Biosimilar Filgrastim : 83% volume, 44% increase in patient access

A sustainable national policy

framework should cover:

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1. Education and information

2. Incentivisation of appropriate early use

3. Collection of Real World Evidence (RWE)

4. Transparent and evolutionary procurement

Value Added Medicines

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What is a Value Added Medicine?

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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

Value added medicines are different to

generic medicines

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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

Value Added Medicines:

An Opportunity for Europe

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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

conditions1

• Total annual cost of

unscheduled events due to

poor inhalation technique:

£18.8 million/year2

1Hansen R et al. Transplant Proc 2007;39(5):1287–1300 2Lewis 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

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EGA - Legal Affairs

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Double dimension: public health & IP

Quality

EGA engagement on counterfeit medicines

Active role with EU institutions

The work on trademarks

The EGA in the international arena

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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

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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

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Questions?

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Sergio Napolitano

EGA Director Legal Affairs and Trade

sergio@egagenerics.com