Biosimilar Development

Introduction Under Section 351(k) of the Public Health Service Act (PHS Act), an abbreviated Biologics License Application (aBLA) for a […]

Introduction The FDA Purple Book is an online database that enables biopharmaceutical researchers and regulatory specialists to assess FDA-licensed Section

Introduction Biosimilar nonclinical toxicity studies are no longer legally required to include in vivo animal testing following the enactment of

Introduction A situation in which a biosimilar comparative efficacy study is still required typically arises when high molecular complexity, a

Introduction The analytical characterization of Interferon Beta-1a Biosimilars involves an extensive evaluation of complex N-glycosylation profiles to establish structural and

Introduction Formal Biosimilar Biological Product Development (BPD) Meetings serve as an essential regulatory bridge between sponsors and the United States

Introduction A specialized Subvisible and Visible Particle Testing Service provides essential physical characterization and quality control data needed to establish

Introduction: Biologics, including monoclonal antibodies (mAbs), recombinant proteins, enzymes, fusion proteins, and biosimilars, are structurally complex medicines whose quality depends

Introduction A chemically synthesized protein may qualify for approval as a biosimilar under Section 351(k) of the Public Health Service

Introduction Understanding how the FDA reviews a 351(k) biosimilar application requires examining a risk-based evaluation framework designed to establish that