To Be Or Not To Be Followon Biologics

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To Be Or Not To BeFollow-on Biologics

• Diane Edquist Dorman
• NORD Corporate CouncilMay 21, 2007

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What do Patients Want?...

• Safe and effective medicines
• Safe, pure potent safe and effective
• Treatments they can afford

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What does NORD Want?...

• Regulatory pathway to approve FOBs
• Protection of ODAs 7-year exclusivity
• Costs patients and healthcare providers can
  afford

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• Safe effective biologics for the treatment of
  rare diseases
• Allow the FDA to determine the science
• Clinical trials may be necessary
• Effective outreach to healthcare providers and
  patients will be necessary

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The Trick is Finding the Right
Balance
Access/ Affordability
Innovation
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Eeny, Meeny, Miney, Mo Exclusivity

• Waxman 0 years?
• Inslee/Green 14 years?
• EU Model 10 years?

Which Way Will Exclusivity Go?
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Competition Fosters Innovation
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Diane Edquist Dorman Vice President, Public
Policy National Organization for Rare Disorders
(NORD) 1050 17th Street, NW, Suite
600 Washington, DC 20036 Office [phone]
ext. 3014 ddorman_at_rarediseases.org