Course Description:
In the rapidly evolving biosimilar landscape, regulatory approval remains a critical challenge for manufacturers seeking to bring these complex products to market. What strategies are most effective when preparing for FDA meetings? How can developers best demonstrate biosimilarity through analytical characterization, clinical study design, and interchangeability data? This webinar will address key regulatory considerations—providing practical guidance on FDA expectations, common submission pitfalls, and successful approaches to navigate the approval pathway from development through commercialization.
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biomanufacturing, biologics organizations; Job function: process design, quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.
Access Duration: Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Though this course is being made available on USP’s Education site, the course content was developed by Pharmatech Associates, a USP company. USP has not independently reviewed or verified the accuracy of the course content.
Speaker:
Claudia Lin, PhD
Biosimilar Quality and Regulatory Strategy Lead, Pharmatech Associates
PhD, Cell and Molecular Biology, University of California, Berkeley
BA, Chemistry, Fudan University