Predicting Follow-On Entry and Evaluating the Risk and

Commercial Opportunity in the Emerging Biosimilar

Landscape

Henry G. Grabowski, Ph.D.

Professor Emeritus

Duke University, the Fuqua School of Business

(Durham, NC)

Christopher-Paul Milne, D.V.M., M.P.H., J.D.

Director of Research, Center for the Study

of Drug Development

Tufts University Medical School (Boston, MA)

Naomi K. Pearce

Vice President, IP, Global Biologics Center of

Excellence

Mylan, Inc (Canonsburg, Pa.)

Moderator

Vincent L. Capuano, Ph.D.

Chair – Hatch-Waxman and Biosimilars

IP Practice Group

Duane Morris LLP (Boston, MA)

DISCLAIMER

The views, positions and opinions expressed in this

presentation are those of the author alone and do not

necessarily reflect the views of his employer, or the

views of any of his colleagues, affiliates or clients.

Nothing in this presentation is intended to provide

legal advice. No attorney-client relationship is

established by virtue of this presentation.

Biosimilar Competition: Lessons From

Europe and Prospects for the US

Henry Grabowski Duke University

American Conference Institute

New York City

June 5, 2014

Pharmaceuticals vs. Biologics

Pharmaceuticals Biologics

Size (MW) Small (<1000) Large (>10,000)

Source Chemical synthesis Cultures of living cells

Form Generally oral solids Often injected or infused

Reimbursement Pharmacy benefit Often medical benefit

Example

Lipitor (anti-cholesterol) Herceptin (breast cancer)

HERCEPTIN

MW =

185,000

LIPITOR

MW = 558.64

European Biosimilar Study*

– Two major biologic products with biosimilars

• Eprex–Epotein alpha

• Neupogen–Filigrastim

– Five European countries in our sample

• Germany, France, UK, Italy, and Sweden

– IMS quarterly data over 2009–2011 period on sales

and standard units

* Henry Grabowski, Rahul Guha, and Maria Salgado. “Biosimilar Competition: Lessons From

Europe.” Nature Reviews: Drug Discovery, February 2014.

European Experience With Biosimilars

• For Epoetins and G-CSF classes, approved biosimilars

reference first generation products (Eprex and Neupogen)

• Biosimilar market shares vary significantly across five

countries and across product classes within a country

• Germany and Sweden have largest overall shares of

biosimilar utilization relative to reference branded biologics

• Biosimilars also compete with longer lasting products

(Aranesp and Neulasta) approved for the same indications

0

100

200

300

400

500

600

QTR 12009

QTR 22009

QTR 32009

QTR 42009

QTR 12010

QTR 22010

QTR 32010

QTR 42010

QTR 12011

QTR 22011

QTR 32011

QTR 42011

Source: IMS MIDAS data; WHO.

Note: The biosimilar group includes Filgrastim-Hexal, Ratiograstim, Biograstim, and Nivestim. The biosimilar reference products are Neupogen and

Biosimilars Effect on Filgrastim-Neulasta

Market Segment, 2009-2011

Germany in 000's

Neulasta

Biosimilar

Reference

Biosimilar

Products

Insights for US Biosimilars From Europe

• Germany and Sweden arguably best comparator

countries to US health care system

• Maximum number of biosimilars introduced in a

country is five (Germany)

• Biosimilar mean price discounts are moderate in size

(25% or less) compared to generic competition

• Incremental innovation in the same therapeutic class

can significantly affect degree of biosimilar utilization

Key Factors Influencing the Economic Environment

for US Biosimilar Competition

• Market opportunities and patent expirations

• FDA Regulatory Standards for Biosimilarity

• Interchangeability vs Biosimilarity Alone

• Actions of Physicians, Insurers, and Patients

• Introduction of Next-Generation Products

Cost of Developing A Biosimilar Product

• Development costs will vary across product classes

• Even less complex biologics (Epos, G-CSFs) are likely to

cost tens of millions of dollars

• More complex biologics (MABs, interferons) have

estimated costs of development ranging from $75 to $150

million

• By contrast, cost of completing bioequivalence studies for

generic drugs is estimated to be $1 - $5 million

Regulatory Requirements to Establish

Interchangeability

• FDA likely to require crossover studies for complex

biological products to establish interchangeability

• These are difficult trials for which to recruit patients, and

costly for companies to perform

• Many firms may choose to submit applications on

biosimilars as therapeutic alternatives rather than

therapeutic equivalents

Nature of Generic / Biosimilar

Competition Pharmaceuticals Biologics

• Low barriers to entry due to low

manufacturing and R&D costs;

multiple generic entrants

• Higher barriers to entry; lower number

of entrants expected

• Price competition • Differentiated competition:

price and quality

• Automatic substitution; rapid loss in

market share

• No automatic substitution; market

share loss expected to be less

significant

• Rapid price decline; generic price

approaches marginal cost

• Price decline expected to be less

significant

• No role for marketing after

generic entry

• More significant role of marketing for

both biologic and biosimilar

Physician and Patient Perspectives

– Nature of disease

– Short term vs maintenance therapy

– New vs continuing patients

– Specialist’s brand persistence and loyalty

– Co-pay differentials to patients

Factors Influencing Choice of Biosimilar vs Reference Brand

Development of Next-Generation Products

• Competition in biopharmaceutical is dynamic and many

biologicals have next generation products in development

• In Feb. 2013, FDA approved Kadcyla, an MAB drug

conjugate combining Herceptin with emtansine

• Biogen is developing a PEGylated version of its interferon

beta 1-a product for multiple sclerosis

• Roche is developing subcutaneous injection

presentations for its Herceptin and Rituxan products

• Next generation products may be in the planning stages

for Avastin and Remidade

Further Research Issues

• Biosimilar prices vs reference brand prices

• Reference brand strategic responses

• Increased demand and access

• Cost savings to payers and patients

Summary and Conclusions

• Biosimilars have large potential commercial opportunities

but they also have high regulatory hurdles

• Competition is likely to be confined in near term to few

entrants and resemble brand to brand competition

• Over the long run, scientific advances may lower the cost of

obtaining biosimilarity and interchangeability designations

• Cost savings to health sector are likely to be relatively

moderate in nature for the foreseeable future

Are Biosimilars Becoming

their own Market Sector?

Christopher-Paul Milne, Director of Research

CSDD, Tufts University School of Medicine, Boston

ACI 5th Forum on Biosimilars

New York City

5-6 June 2014

Biologics

Originals

True Innovator

Bio-Betters

Non Originals

Biosimilars Non Original

Biologics

Eylea Pegasys Inflectra Reditux Example

A Biosimilar by Any Other Name

CLASSIFICATION OF BIOLOGICS

To support consistent analyses across geographies, therapies, and manufacturers, IMS Health has established an industry-verified categorization of biologics. Although not every product fits neatly into these classifications, the schema applies in most instances.

Within IMS MIDAS, biosimilars are those biologics that are non-original copies of innovative brands and that have been approved for marketing via a dedicated regulatory pathway, such as has been created in the EU, US, and Japan. Non-original biologics (NOBs) are those copies of innovative brands that have not been approved through such a dedicated pathway. Typically, they are introduced in emerging markets.

IMS Forecast for Biologics/Biosimilars/Non-

Original Biologics (NOBs)

Source: IMS Health, MIDAS, MAT Dec 2012. IMS analysis & estimates. NOBs are recombinant and synthesized only.

Global Market Facts and Futures

In Europe, 19 biosimilars approved for 10 products as of April 2014

Overall biosimilars market is worth $2.7bn in 2013, expected to climb to $20bn by 2018

Biosimilar development could take 7-8 years and cost $100-250m

Biologics in general have increased their share of the total biopharma market gradually from 11% in 2002 ($46bn) to projected 20% ($221bn) in 2017, while during that same time frame biosimilars and NOBs have vaulted from 0.3% to 2-5% share of biologics…impressive in relative terms but small in the absolute

To put it in global context: biosimilars account for <0.5% of mature market biologic spend, while NOBs account for >10% of pharmerging biologics spend by value (Source: IMS Nov 2013, The Global Use of

Medicines: Outlook through 2017)

BRIC-A-PAC…where is the market at?

• EMA/FDA “biosimilars cluster” set

up in 2011

• Emerging guidance supports use

of reference products sourced from

other region if scientifically

justifiable

• EMA is moving toward acceptance

of reference products from outside

EU to facilitate global biosimilar

development

• FDA draft guidance says that a

biosimilar sponsor can use non-

US-licensed comparator in certain

studies of similarity

Will Finding the Path thru Jungle of ‘Foreign’ Reference

Products be the Path to Harmonization!

EU Physician & Payer Views In EU-5 study of physicians, only 35% said they were likely to prescribe a new

biosimilar for RA within a year of launch and when asked about their concerns, reported purity vs. the originator product, immunogenicity, and efficacy as the most common (PharmaVoice March 2014)

Even European doctors are not very familiar with biosimilars (only 22%), while 24% cannot define or have not heard about biosimilars before (and the majority are somewhere in between); however, 72% consider it “critical” or “very important” to decide whether a patient should receive a biosimilar or the originator product (Alliance for Safe Biologic Medicines survey of ~500 MDs in France, Germany, Italy, Spain, and the UK)

NICE programme director said limited entry to UK because of resistance from MDs due to: lack of physician awareness, concerns over SEQ; uncertainty of benefits for patients, complexity of products, and lack of manufacturer support services (SCRIP, Getting doctors to like biosimilars, Ian Schofield, 24 April 2014)

In any case, however, NICE is preparing for a “potentially large volume” of biosimilars in collaboration with MHRA, looking not at a single technology assessment approach but part of a multiple TA including the reference product in the relevant disease area, but may produce an “evidence sumary” for some individual biosimilars, leaving the choice between originator or biosimilar up to physician because suitability and interchangeability (re: immunogenicity and switchability respectively) cannot be assumed (SCRIP, Getting doctors to like biosimilars, Ian Schofield, 24 April 2014)

U.S. Physician Survey Results

• Almost all physicians believe that if a biosimilar is approved by the FDA

the product will perform similarly to the originator biologic with regard

to safety and efficacy, and most say likely to prescribe them when they

are approved by the FDA

• Additionally, the majority of physicians feel comfortable switching an

existing patient from the originator biologic to a biosimilar

• Less than 1/3 of physicians surveyed would prescribe a biosimilar for

an indication for which it is not approved, but for which the originator

biologic is labeled

• Efficacy and safety are the two most important considerations that

influence a physician’s decision to prescribe a biosimilar, while out-of-

pocket costs to patients, price of treatment, and immunogenicity have

less influence on physician decision

• Almost all physicians in favor of instituting coverage with evidence

development policies for biosimilars, following FDA approval, provided

that patients enroll in post-approval clinical trials to assess real-world

effectiveness and safety

Tufts CSDD, Joshua Cohen, 2014 forthcoming

U.S. Payer Survey Results • Safety and efficacy were the most important factors when payers considered

adoption of biosimilars on formularies, while cost-effectiveness and out-of-

pocket costs were least

• Almost all payers intend to include biosimilars on their formulary. All payers

intend to promote biosimilar uptake by differentiating between the originator

biologic and biosimilar through the use of formulary tiering to steer patients and

physicians towards biosimilars

• Most payers said they would recommend therapeutic switching of biosimilars,

while all said that therapeutic switching would be automatic at some point in the

near future

• Majority of payers supported extrapolating the use of a biosimilar to an

indication for which it is not approved, but for which the originator biologic has a

labeled indication

• Almost all anticipated that growth hormone products being eligible for

therapeutic switching first, followed by insulins, then erythropoiesis stimulating

proteins, while tumor necrosis factor-α blockers and human epidermal growth

factor receptor (HER2) inhibitors would be switched last, consistent with payers’

level of comfort with interchangeability designation

• Seventy-five percent of payer respondents expect biosimilars to have a 15-30%

price discount., while the remainder of respondents thinks a larger discount is

likely

Tufts CSDD, Joshua Cohen, 2014 forthcoming

The Elephant in the Room…

• …high cost of new innovator

biologics

• While specialty drugs accounted

for just 1% of prescriptions in 2013,

they accounted for 50% of

insurance company’s drug

spending

• Specialty category – which is 75%

biologics – is growing at about

15% per year, while non-specialty

drugs are growing at 5%

• Drugs accounted for 10% of

Aetna’s total healthcare spending

last year

(Source: Aetna, as reported in Biocentury, ‘Biosimilar

Schism,’ 10 Feb 2014: A1)

Top Biologic Patent Expirations

Upcoming Global Sales US$

Billion

US Expiry Date

Adalimumab (Humira) 9.1 2016

Etanercept (Enbrel) 7.7 2028

Infliximab (Remicade) 7.5 2018

Insulin Glargine (Lantus) 7.1 2014

Rituximab (Mabthera) 6.2 2016

Bevacizumab (Avastin) 5.6 2017

Insulin Aspart (Novomix,

Novorapid)

5.4 2015

Trastuzumab (Herceptin) 5.1 2019

Glatiramer Acetate (Copaxone) 4.7 2014

Pegfilgastrim (Neulasta) 4.2 2014

Ranibizumab (Lucentis) 4.2 2016

Source: UNS NUDASM 06/2013, IMS Patent focus; Copaxone may see a conventional generic copy, not a biosimilar

Why the Low VC Rating if Investment Potential so High?

Source: Adapted from Pink Sheet, 17 Oct. 2012: 17

Compelling Neutral Not Compelling

Mixed Market Signals

Biologics, due to production efficiency, double-digit price increases and lack of competition, can have profit margins in the 90% range

Existing patients are 80% of the potential market for a new biologic in a given year and if significant switch-over is prevented by offering rebates as high as 50% then this can act as a significant barrier for biosimilars trying to crack brand loyalty (Source: PS 17 Feb 2014:11)

Experience in Europe has been mixed with IMS reporting that 14 biosimilars approved as of 2011 took only an 11% share of the accessible biologics market at only 10-30% discount to reference price (PharmaVoice March 2014, What’s next for biosimilars)

Biosimilar mAbs are “next big thing” as there were already >70 in the pipeline by end of 2012 (Biosimilars seven years on, McKinsey & Co. 2012)

Cumulative sales of biosimilars from 2006 to 2011 were only $1.2 bn, while R&D and manufacturing investment for 7 biosimilar dossiers approved by that time amounted to $1-1.5bn (Biosimilars seven years on, McKinsey & Co. 2012)

Scary but True…U.S. is Pivotal

Market! Interest is growing…in June 2011, CDER had received 16 requests for initial meetings to

discuss biosimilar development programs, and by mid-2013, it was 56, six months later it was

62 involving 13 reference products, and CDER had received 22 INDs (Scrip, ‘As US biosimilar

activity rises…’, Ian Schofield, 17 Feb 2014)

FDA recently reports (March 2014) that it has had several late-stage Biosimilar Product

Development meetings (aka BPD-4), which are essentially pre-application meetings

Issues with approval by FDA as Jenkins says it may require a change of mindset (and

development strategy) because you can’t overcome a lack of analytical similarity by doing

clinical trials and not seeing any differences because they are actually a relatively insensitive

tool for that purpose (Interview with John Jenkins, Head of CDER, RPM Report, March 4, 2014)

Phrases they use a lot are “totality of the evidence”, looking at all the evidence but with

flexibility as represented by the second phrase representing the principle of “residual

uncertainty” such that the studies address specific questions not just a cook book process of

…do this, do that, and you’re done....

Most of the biosimilar programs are concentrated in just a few therapeutic areas…oncology

and rheumatology indications…so other divisions have not been heavily involved and it’s

taking some time to educate and re-educate staff in the other divisions about the difference

between developing a new drug and showing that a drug being developed is highly similar and

not clinically meaningfully different from the reference drug. (Interview with John Jenkins, Head of

CDER, RPM Report, March 4, 2014)

FDA Division Performance Scores

DiMasi JA, Milne C-P, Tabarrok A. An FDA report card: wide variance in performance found

among agency’s drug review divisions. Project FDA Report April 2014; (No. 7). Manhattan

Institute for Policy Research http://www.manhattan-institute.org/html/fda_07.htm#.U1_t61dUinw

Biosimilars…leaping at the opportunity… or

losing your head over the complexity!

…product sponsor

experiences so far would

justify either response

Surprisingly…stakeholder

views in US appear more

favorable than in EU, but then

again, biosimilars not really

“in” the US yet

Ballooning prices for

innovator biologics with

shrinking healthcare dollar

means something has to give

Mixed market signals means

that U.S. is pivotal for

biosimilars as a sustainable

market segment!

ACI Biosimilars 4 – 6 June 2014

Naomi Pearce VP, IP, Global Biologics COE

38

• Why biosimilars?

• What does the current biosimilars market look

like?

• Which biosimilars?

– Which products are under development?

– What are the relevant factors in product choice?

• What are the current barriers to biosimilar market

entry?

• What can be done to facilitate/expedite biosimilars

entry into the US market?

Overview

39

Why Biosimilars?

What is the market opportunity?

Why Biosimilars? By 2016, 7 of the top 10 pharmaceuticals worldwide will be biologics and insulin*

2010 to 2020: Biologics expected to

grow to $250B

In the US alone, from 2005 to 2010

biologic sales were over $68Bn

By 2017, $70Bn of biologics will be off

patent

Aging population, high cost of new drugs

and greater patient awareness will lead

to increased use of biologics

*Source: Evaluate Pharma 2012

Product Type 2016 Revenue

(USD Bn)

1: Humira Biologic 10.1

2: Avastin Biologic 8.9

3: Enbrel Biologic 7.3

4. Rituxan Biologic 6.8

5: Crestor Small molecule 6.3

6: Herceptin Biologic 6.2

7. Remicade Biologic 5.7

8: Lantus Insulin 5.3

9. Seretide / Advair Respiratory / device

5.2

10. Revlimid Small molecule 5.2

40

Why Biosimilars? To enable worldwide access to critical care biologics

Access to biologics is limited worldwide due to high prices

41

• Biosimilar success & realized savings

– Germany saved over € 60Million in 12 months upon entry of biosimilar

erythropoetins1

– Up to 40% decrease in treatment costs seen for patients in EU and Asia

due to biosimilar competition2

• Projected US savings due to biosimilars

– US CBO estimated biosimilars competition would reduce spending by

$25B USD from 2009 – 2018, saving the government $6B3

– In 2007, Express Scripts estimates savings to US healthcare system of

$71B USD over 10 years4

– In 2013, Express Scripts estimates savings to US healthcare system of

$250B USD from 2014-2024 if 11 likeliest biosimilar targets enter the

market2

Why Biosimilars? To reduce costs for patients, governments, and payers

(1) IHS “Generics and Biosimilars Market Access in Europe” . October 25, 2011

(2) Express Scripts. The 250 Billion Potential Savings of Biosimilars. April 23, 2013 http://lab.express-scripts.com/insights/industry-updates/the-$250-billion-potential-

of-biosimilars#sthash.rv7Q6TTH.dpuf

(3) Congressional Budget Office. BPCIA Act of 2007; June 25, 2008

(4) S Miller and J Houts, “Potential Savings of Biogenerics in the United States,” ExpressScripts (February 2007)

(5) Adapted from: Lanthier, et.al. “Economic issues with follow-on protein products”. Nature Reviews Drug Discovery 7; (Sept. 2008)

(6) Express Scripts. The 250 Billion Potential Savings of Biosimilars. April 23, 2013

42

US Government Spending

• 2009:

– Medicare spent more on Epogen® than the entire FDA budget for that year1.

• 2010:

– spending on the top 8 biologics was >43% of Medicare Part B’s total budget, and spending

for biologics was >25% of the total US drug bill2

• …By 2020:

– biologics are expected to account for 75% of all US drug spending3

• Biologics are the fastest growing health care-related expense (with the exception of

diagnostic imaging tests).

• Congressional Research Service concluded that spending on biologics will be

unsustainable without the approval of biosimilars to “enable market competition and

reduction in prices”4

Why Biosimilars? To bring savings to the economy

1. GPhA. Generic Drug Savings in the US. Fourth Annual Edition. 2012

2. "Biosimilars," Health Affairs, October 10, 2013.

3. Rockerfeller et.al. Senator Letter to Commissioner Hamburg. October 23, 2013.

4. Johnson, J. A. (2010, April 26). FDA Regulation of Follow-On Biologics. Congressional Research Service; 7-5700:RL34045. www.crs.gov

Why Biosimilars? Biologics and insulins market by product and country

Of every $10 spent on biologic medicines, $5 is spent on U.S. patients, $2 goes to EU5 and $1 goes to Japan (the rest is divided by all other RoW countries)

Biologics revenue of $166B and grew at 8.5%

CAGR (2008 – 2012) 7 major markets (US, EU5, Japan) responsible for 80% of

biological expenditure

Pharmacy in Kenya

At Mylan, our purpose is

44

OUR MISSION: At Mylan, we are committed to setting new standards in health

care. Working together around the world to provide 7 billion people access to high

quality medicine, we innovate to satisfy unmet needs; make reliability and service

excellence a habit; do what’s right, not what’s easy; and impact the future through

passionate global leadership.

To us, our mission isn't just words.

It's a cause we've made personal.

45

Pharmacy in Kenya

At Mylan, our purpose is

46

Feb 2014: Mylan launches the worlds 1st biosimilar trastuzumab (HertrazTM) with the patient as the centre of focus

“treating HER”

47

• On market: – Filgrastim (8 companies, EU & Asia) - EPO (5 companies, EU & Asia)

– Somatropin (2 companies, EU & Asia) - Follitropin (2 companies, EU)

– Trastuzumab (3 companies, Asia) - Infliximab (2 companies, EU & Asia)

• In development:

– Per Bernstein Research1:

• According to publicly available information, 45 products have entered clinical trials (up from 37 in Aug

2013)

– 8 products approved; 22 in pivotal trials; 15 in PK/PD trials

– Per GaBI2:

• 125 different development programs exist for biosimilars to the world’s top 5 biologics products2

• In the Courts: – EU: Hospira (UK & continental Europe) - Trastuzumab

– US: Hospira & Celltrion – Infliximab

– US: Lilly - Glargine

– US: Sandoz - Etanercept

Biosimilars Current biosimilar market

1) Bernstein Research (A. Gal) “Biosimilars: who is doing what? May 2014 – snapshot of the biosimilar industry pipeline” 16 May 2014.

2) Generics and Biosimilars Initiative http://www.gabionline.net/Biosimilars/General/Biosimilars-on-the-horizon, 23 May 2014

48

• EMEA

– Guidelines approved 2005

– First biosimilar product approved 2006

– Biosimilars to 5 products on market

• In AU:

– Guidelines approved 2008

– First biosimilar product approved 2010

– Biosimilars to 3 products on market

• In the US:

– BPCIA enacted 2010

– No finalized guidelines

– No biosimilar product approved or filed

Biosimilars Current biosimilar market

49

• Commercial – Portfolio fit

– Sales force

– Likely competitive landscape

– Expected return on development/litigation “investment”

– Regions of interest and pathway considerations

• R&D – Capability

– Capacity

– Development timing

• Legal – FTO dates, litigation costs/timing/risk

– Pathway to obtain patent certainty

• Regulatory – Whether the product is approvable as a biosimilar

– Whether the approval will be timely

– Pathway considerations

Which Biosimilar? Relevant factors in product choice

50

• R&D challenges

– cost

– complexity

• Regulatory challenges

– New pathway

• US process untested

• No finalized guidances

• Requirements not clearly defined

• No guidance on interchangeability

• FDA has been slow to advance biosimilars, adopting a “wait and see”/sequential approach

• Since BPCIA enactment (2010), no application filed or approved

– Brand company regulatory/legal litigation for the purpose of delay expected

• Commercial/market structure uncertainty

– Market movements hard to predict 10 years in advance

• Originators transitioning market to new products/regimes/formulations?

– Uncertainty regarding INN naming/substitution/interchangeability/prescribing practice

Market barriers Multiple barriers to US biosimilar market entry

51

• Legal uncertainties

– No simple path to pre-launch patent certainty in the US

• ABLA litigation pathway

– Untested – no jurisprudence

– Multiple rounds of litigation required to produce “certainty”?

» Newly granted/licensed patents

» Patents withheld from first list

» non exclusively licensed patents – outside ABLA

» Non originator patents (eg platform) – outside ABLA

• Is IPR the only way to pre-launch certainty?

• Will the Fed Cir in Sandoz v Amgen remove the pre-filing DJ option?

– Patent law challenges

• Greater number of patents, platform patents & interested patentees

• Process patents may be more important than in the small molecule context

• Greater uncertainty in FTO clearances

– Technology lag between industry and Court

– Lack of jurisprudence

• Submarine patent risk

Market barriers Multiple barriers to biosimilar market entry

52

• Because 351(k) litigation pathway has not been

used, weak US patents have not been challenged,

and “monopoly” prices continue

• Lack of biosimilar competition results in very high

prices continuing long after expiry of market entry

barrier patents

• Delayed US market entry has meant forecasted

Government savings foregone

Market barriers Economic impact for the US

53

• When will biosimilars enter the US market?

• What can be done to expedite US biosimilar entry?

– Increase alignment between regulatory standards (US,

EU, AU, CA) to enable manufacturers to develop one

global product

– Finalize FDA guidances (including interchangeability)

including requirements for timely processing of

applications

– Provide dedicated and appropriate resources for

biosimilars reviews at the FDA

• Create dedicated Office of Biosimilars

– Support use of same INNs, and eliminate state

substitution notification requirements

When can we expect Biosimilars in the USA? ….what can be done to expedite US biosimilar market entry?

Providing 7 billion people

access to high quality medicine

Breaking barriers to access

Staying true to our core values

Consistently achieving financial

targets

Positioning the company for

future growth

& Doing well Doing good

54