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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Regulatory approvals of therapeutic biologics: continuing progress or plateauing out compared with those of small
Charles Oo1, Joanna M Sadowska2, Sherwin K B Sy3
1SunLife Biopharma, Morris Plains, NJ, USA.
Abstract:
Here, we draw upon US Food and Drug Administration (FDA) drug approval trends to examine the evolving developmental priorities between biologics and small molecules (SMs). We outline distinguishing features of biologics and SMs, including crucial aspects of research and development (R&D) costs, manufacturing complexity, efficacy and safety, expedited development and review pathways, patent and exclusivity, bioengineering versatility, and biosimilar competition. Although biologics have garnered increasing attention, their approval trajectory remains nonexponential, and they have yet to consistently overtake SMs as the predominant therapeutic class. Looking ahead, our therapeutic frontier is likely to be defined by an integrative paradigm, one in which biologics, SMs, and combination therapies converge to offer synergistic solutions for treating human disease.
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