Transcript The Biosimilars Act

The Biosimilars Act—A Basic Introduction
Michael H. Hinckle
K&L Gates
Research Triangle Park, NC
(919) 466-1115
[email protected]
Copyright © 2010 by K&L Gates LLP. All rights reserved.
Background
 Small molecule drugs approved under the
Federal Food, Drug, and Cosmetic Act
 Generic process available (ANDA)
 Biologics licensed under the Public Health
Service Act
 Until recently, no “generic” process available
 “Biologics Price Competition and Innovation Act”
(enacted as Title VII of the Patient Protection and
Affordable Care Act) created a pathway for FDA to
approve competing versions of currently marketed
biologic drugs.
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Biosimilar Approvals
 Approval Pathways
 Biosimilar
 “highly similar” except for “minor differences in clinically
inactive components”
 same mechanism of action (if known), route of admin, dosage
form, strength, and labeling
 requires (unless waived) analytical, animal, and one or more
clinical studies
 Interchangeable
 Biosimilar plus “expected to produce same clinical result …in
any given patient”
 for products administered more than once—no reduction in
safety or efficacy when alternating or switching between
biosimilar and reference product.
 requirements left to FDA
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Data and Market Exclusivity
 Reference Products
 12 years market exclusivity
 4 years data exclusivity
 No exclusivity for supplements, new indications,
dosing schedules, dosage forms, delivery
systems/devices or strengths
 But, exclusivity for “modification to structure” that
results in change in safety, purity or potency
 First Interchangeable Biosimilar Product
 Up to one year of being only interchangeable
product
 Can be shortened if unable to launch
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Key Elements of Patent Dispute Process
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Full application submitted to reference sponsor
Exchange of Patent lists and detailed statements
“Patent Resolution Negotiation”
Designation of Patents for Litigation—biosimilar
applicant controls the number of patents that
may be listed by each side
 No “30-month stay” of biosimilar approval
 But, second bite at the apple—biosimilar
applicant must give 180 days notice prior to
launch and reference sponsor may seek P.I. on
ANY patent that was on its initial list.
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Michael H. Hinckle
K&L Gates LLP
Research Triangle Park, NC
(919) 466-1115
[email protected]
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