Title: Assessing Biosimilarity and Interchangeability: Issues and Recent Development
Presenter: Shein-Chung Chow
Date and Time: Tuesday, June 19, 2018, 12:00 p.m. – 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section
Registration Deadline: Friday, June 15, at 12:00 p.m. Eastern time
Biological drugs are much more complicated than chemically synthesized, small-molecule drugs. For instance, their size is much larger and structure is more complicated. In addition, they can be sensitive to environmental conditions such as light, temperature or pressure. Moreover, they may expose patients to immunogenic reactions. Consequently, the assessment of biosimilarity and interchangeability calls for greater circumspection than the evaluation of bioequivalence. The FDA recommends the use of stepwise approach for obtaining totality-of-the-evidence for demonstration of biosimilarity and interchangeability. The stepwise approach involves analytical similarity assessment, animal studies for toxicity, pharmacokinetic and pharmacodynamics (PK/PD) studies for pharmacological activities, clinical studies including immunogenicity for safety, tolerability, and efficacy. The present communication discusses some current issues and recent development related to the assessment of biosimilarity and interchangeability of biosimilar products. The current issues include (1) biosimilar versus biobetter, (2) how many biosimilar studies are required?, (3) multiple reference products, (4) criteria for highly variable drug products, (5) development of biosimilarity index, (6) analytical similarity assessment for critical quality attributes, (7) drug interchangeability in terms of switching and alternation, (8) study designs that are useful for the assessment of biosimilarity and drug interchangeability, and (9) the issue of (post-approval) non-medical switching, (10) extrapolation of data (both analytical and clinical) across different indications. These issues and corresponding recent development will be discussed.
Biopharmaceutical Section Members: $0
ASA Members: $59
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Registration is now closed.
Registered persons will be sent an email the afternoon of Friday, June 15, with the access information to join the webinar and the link to download and print a copy of the presentation slides.