1. Beyond the Regulatory Process:
Creating a Market for Biosimilars
Gil Bashe
Executive Vice President
MakovskyHealth
212.508.9672
gbashe@makovsky.com 1
2. 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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3. Snapshot US
Laws and Regulations Payer Perspective
March 2010: biosimilars must be No „„A‟‟ rating in FDA‟s Orange Book.
subject to at least one clinical trial to
demonstrate safety and efficacy
Analytical studies that demonstrate Pharmacists or hospitals may not
that the biological product is highly substitute automatically a biosimilar for
similar to the reference product
notwithstanding minor differences in brand.
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.
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4. Snapshot Europe
Laws and Regulations Payer Perspective
EMEA requires extensive testing Decision of interchangeability of
biosimilars and innovator made by
EMEA takes a case-by-case individual member states
approach
France, Spain and Netherlands ban
Biosimilars are required to undergo pharmacists from substituting a
post-marketing monitoring just like biosimilar version if a physician has
new innovative biologies prescribed the original
Requires “differences between the
similar biological medicinal product UK has not banned substitution;
and the reference medicinal however, has said it doesn‟t expect it
product are justified by appropriate to occur.
studies”
10 years of market exclusivity for
innovator.
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6. 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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7. Connecting the Confidence Continuum
Patient/caregivers
Government Prescribers
Payers Biosimilar Conversion FDA/EMEA
KTLs Specialty distribution
Media
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8. Case Study 1-rhGH
The 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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9. 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.
Ameet Mallik, Global Head Sandoz Biopharmaceuticals
November 22, 2010
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10. Case Study 2 – Hospira
The 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
September 30, 2009
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
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12. 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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13. 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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