Biosimilars Biosimilars The Evolving Pathway to Licensure The - - PowerPoint PPT Presentation
Biosimilars Biosimilars The Evolving Pathway to Licensure The Evolving Pathway to Licensure BIO International Convention BIO International Convention June 28, 2011 June 28, 2011 David G. Adams David G. Adams Venable LLP Venable LLP 202-
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June 28, 2011 June 28, 2011
David G. Adams David G. Adams Venable LLP Venable LLP 202 202-
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8014 dadams@venable.com dadams@venable.com
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Healthcare Reform
Signed into law March 23
Public Health Service Act Amended
New 42 U.S.C. 262(k)
Licensure of
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Biosimilarity
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“Notwithstanding minor differences in clinically inactive Notwithstanding minor differences in clinically inactive components components” ”
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Interchangeability
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Risk of safety or diminished efficacy of alternating or
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Studies re characterization, safety, and
Analytical studies to show
Animal studies
Including assessment of toxicity
Clinical study or studies
including immunogenicity
For one or more appropriate conditions of Reference
FDA can waive any of these study
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Pediatric Studies required for approval of NDAs
Biosimilar considered to be new active ingredient
Unless FDA determines Biosimilar to be
Unless FDA determines Biosimilar to be “ “interchangeable interchangeable” ” Other Information
Same
To extent known for Reference Product
To extent known for Reference Product
Conditions licensed for Reference Product
Same strength, dosage form, and route of administration
Manufacturing facility/processes
REMS if requested by FDA
Optional information
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No pathway analogous to 505(b)(2)
No new condition of use
No new active ingredient
No difference in strength, dosage form, route of
No reliance on more than one Reference Product
No clinically meaningful differences in safety or
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Exclusivity for original BLA licensure
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Delay calculated from date of original licensure of
No new exclusivity for product changes made
Pediatric and orphan exclusivity
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Limited exclusivity for new BLA for modification to
Same sponsor
Same manufacturer
Exclusivity only for:
Modification to
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Possible exclusivity for OTC switch, different safety or efficac
Possible exclusivity for OTC switch, different safety or efficacy y profile, new sponsor and manufacturer profile, new sponsor and manufacturer
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For first biosimilar determined interchangeable
Delays determination of interchangeability for
Periods of delay
One year after the first commercial marketing
18 months after final court decision or dismissal re all
42 two months after determination of interchangeability
18 months after licensure
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Proteins and analogous products added to definition
Exception for chemically processed polypeptides
Some classes of proteins historically approved as
Hormones
Insulin
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During 10
NDA or ANDA can be filed for product within class of
Unless there is a BLA for an appropriate reference drug
10 years after enactment date:
Proteins approved as drugs deemed to be licensed as
No protein application can be submitted under drug
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Patent resolution outside of FDA approval
Processes for FDA guidance documents
Public input
Process for FDA recommendation re user fees
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Acceptable range of structural differences
Post translational modifications
Necessity for clinical trials
Demonstration of clinical similarity
Comparisons to drugs approved in foreign
Extrapolation across indications
Clinical superiority
Evidence demonstrating interchangeability
Nomenclature and labeling
Modifications entitled to exclusivity
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