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Beyond the Regulatory Process:

Creating a Market for Biosimilars

Gil BasheExecutive Vice President

MakovskyHealth

212.508.9672

gbashe@makovsky.com

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The long-term issue for biosimilars will be market

penetration. That is and will remain the heart of the

biosimilar challenge in Europe and in the US… as for how

biosimilars will get to patients after that: I’m not sure if

there’s a model yet.

Ronny Gal, Analyst

Bernstein and Company

May 19, 2009

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Snapshot US

Laws and Regulations March 2010: biosimilars must be subject to at least one clinical trial to demonstrate safety and efficacy

Analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components

FDA can determine that some of these data are unnecessary

Administration route, dosage form, and biological product strength are the same as the reference product

12 years market exclusivity to innovator.

Payer Perspective

No „„A‟‟ rating in FDA‟s Orange Book.

Pharmacists or hospitals may not

substitute automatically a biosimilar for

brand.

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Snapshot Europe

Laws and Regulations Payer Perspective

Decision of interchangeability of

biosimilars and innovator made by

individual member states

France, Spain and Netherlands ban

pharmacists from substituting a

biosimilar version if a physician has

prescribed the original

UK has not banned substitution;

however, has said it doesn‟t expect it

to occur.

EMEA requires extensive testing

EMEA takes a case-by-case

approach

Biosimilars are required to undergo

post-marketing monitoring just like

new innovative biologies

Requires “differences between the

similar biological medicinal product

and the reference medicinal

product are justified by appropriate

studies”

10 years of market exclusivity for

innovator.

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Different Market Dynamic From Generics

Market Share Generics Market Share Biosimilars

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Shifting Operations from Process to Patient

Current focus of biosimilar companies is on regulatory

process, overcoming legal hurdles, approval,

manufacturing and product distribution channels

Consider all of the day-to-day operational logistics and

create buy-in from managed care, physicians and patients

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Connecting the Confidence Continuum

Patient/caregivers

PrescribersGovernment

Payers FDA/EMEABiosimilar Conversion

KTLs

Media

Specialty distribution

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Case Study 1-rhGHThe Case for Patient Support

• Five patent-protected products dominate

US market

• FDA approves Omnitrope for US market

in 2006

• KOLs concern for safety and compared

growth effect

• Omnitrope 2007 sales - $7MM - just

0.3% of rhGH market

1. No data

2. No patient support services

3. No comparable device vehicle

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Case Study 1-rhGH

• OmniSource patient support program

created

• Save As You Grow coupon program

• Approval for two doses in pen applicators

• In the US, the brand has overtaken

Teva‟s Tev-Tropin as leading follow-on

human growth hormone, while more than

30% of naïve patients in Europe are now

being treated with Omnitrope

As a company, we over-estimated the

importance of price alone. Healthcare

stakeholders [doctors, payers and

patients] care about cost when other

things are equivalent.

November 22, 2010

Ameet Mallik, Global Head Sandoz Biopharmaceuticals

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Case Study 2 – HospiraThe Case for Data

• Retacrit was studied to show it is comparable with the

reference medicine, Eprex/Erypo, in experimental models and

in humans

• Rigorous Phase III clinical trial demonstrating comparable

efficacy and safety between epoetin zeta and the reference

product, epoetin alfa, when administered SC in patients with

end-stage renal failure on chronic haemodialysis

• CHMP concluded, in accordance with EU requirements,

Retacrit has been shown to have a comparable quality, safety

and efficacy profile to Eprex/Erypo

• 12% market share in 2010 (Hospira Q4 2010 earnings call)

We've been growing faster than the market, and we really

believe we can continue to grow faster than the market, I see

that going on for an extended period of time.

Chris Begley, CEO, Hospira

1. Data for prescribers and payers-almost 1,000 patient years

2. Clear messages on cost savings for payers

3. Clear messages on government advocacy

4. Patient safety and support initiatives

September 30, 2009

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Biosimilar Conversations in Social Media

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Elements for Brand Uptake

Corporate Reputation

Scientific Process

Legal and Regulatory Capacity

Quality GMP

Regional Approval

KOL/Advocacy

Patient Support

Services

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What separates one company from the next is that we’re

not treated like the customers that we are, but like actual

patients.

Kevin R. Kline, Patient

February 17, 2009

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Questions?

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Gil BasheExecutive Vice President

MakovskyHealth212.508.9672

gbashe@makovsky.com