On February 9, 2012, the U.S. Food and Drug Administration (“FDA”) released three draft guidance documents related to implementation of the Biologics Price Control and Innovation Act of 2009 (“BPCIA”):
Comments regarding the draft guidance should be submitted to the FDA by April 16, 2012, before the Agency begins finalizing the guidance. 77 Fed. Reg. 8883-86. This article outlines the first draft guidance documents that the FDA has issued regarding the implementation of the BPCIA.
These are the first draft guidance documents that the FDA has issued regarding the implementation of the BPCIA. While they are limited in scope in terms of the product class (proteins) and type of follow-on biologic (biosimilar rather than interchangeable) they address, these guidance documents illuminate some useful practice points.
A. Biosimilarity (Not Interchangeability)
B. Therapeutic Protein Products
C. Applications Under § 351(k) of the PHS Act
A. Protein
B. Chemically Synthesized Polypeptide
C. Peptide
A. Stepwise Approach to Demonstrate Biosimilarity
1. Structural and Functional Characterization
2. Animal Data
a. Animal Toxicity Studies
b. Animal Pharmacokinetic (PK) and Pharmacodynamic (PD)
Measures
c. Animal Immunogenicity Studies
3. Human Studies
a. PK/PD Studies
b. Clinical Immunogenicity Studies
c. Comparative Clinical Safety and Effectiveness Data
B. Risk-based Totality of the Evidence in Assessing Biosimilarity
1. Some Minor Structural/Formulation Differences May Be
Compatible with a Finding of Biosimilarity
2. Delivery Device/Container Closure Differences May Be
Compatible with a Finding of Biosimilarity
C. Product-by-Product Assessment
A. Expression System
B. Manufacturing Process
C. Assessment of Physiochemical Properties
D. Functional Activities
E. Receptor Binding and Immunochemical Properties
F. Impurities
G. Reference Product and Reference Standards
H. Finished Drug Product
I. Stability
A. Reliance on Non-U.S. Licensed Product Comparisons
B. Extrapolating to Other Indications
C. Publicly Available Information
Copyright © Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
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