Biosimilars – Understanding Regulatory Challenges™

Available Locations

This is a Core Course for the following Certification Track(s):

  • (BDCP) Biopharmaceutical Development Certified Professional


    Course Description

    In the United States, much excitement has been generated since the passage of the Biologics Price Competition and Innovation Act (BPCI) of 2009. This law establishes an abbreviated market approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a FDA-licensed marketed biologic. However, much confusion has arisen over exactly what this new abbreviated regulatory pathway actually means, and what it will look like when fully implemented by the FDA.

    To better understand what the developing FDA biosimilar pathway might look like, this course will closely examine the existing regulatory guidelines from the European Medicine Agency (EMA) and the World Health Organization (WHO), and compare them to the draft FDA guidances. Insights and practical suggestions to help your company enter the biosimilar biological product market will be provided by examining what has worked, and what has not, for the existing market-approved EMA biosimilars and FDA follow-on-proteins.

    Who Should Attend

    This biosimilars training course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a regulatory strategy for entering into biosimilars, including Project Managers, Regulatory Affairs, Manufacturing and Quality personnel.

    Additionally, this course will be of benefit to those needing to understand Food & Drug Administration (FDA), European Medicines Agency (EMA) and World Health Organization (WHO) perspectives on biosimilars, and the differences in how these agencies view these products.

    Learning Objectives

    At the end of the 2 day course you will:

    • Gain a firm understanding of the CMC, Nonclinical and Clinical regulatory requirements and expectations (FDA, EMA and WHO) for biosimilar biological products
    • Appreciate why biosimilars are not treated by the regulatory authorities as bio-generics, and the significant differences between biosimilars and generic chemical drugs
    • Learn the totality of what is to be present in the submitted comprehensive, scientific biosimilarity exercise – what has worked, what has not, in bringing biosimilars into the marketplace.

    Frequently Asked Questions

    Does the course cover FDA and international concerns?

    The course covers all aspects of biosimilar requirements and guidance from the FDA, European Medicine Agency (EMA), and World Health Organization (WHO).

    Does the course cover CMC, Nonclinical and Clinical concerns?

    The course covers expectations for Chemistry, Manufacturing & Control (CMC), Nonclincal (i.e., animal studies) and Clinical (i.e., human studies) biosimilarity studies.