Pharma / Biotech
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.
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.
Biosimilars Are Not "Bio-Generics"
Regulatory Pathways For Biosimilars
Biosimilar Meetings With Regulatory Agencies
General Principles For Biosimilars:
Biosimilarity Step 1: CMC Comparability
Biosimilarity Step 2: NONCLINICAL Comparability:
Biosimilarity Step 3: CLINICAL Comparability:
Biosimilar Lessons Learned and the Future
At the end of the 2 day course you will:
The course covers all aspects of biosimilar requirements and guidance from the FDA, European Medicine Agency (EMA), and World Health Organization (WHO).
The course covers expectations for Chemistry, Manufacturing & Control (CMC), Nonclincal (i.e., animal studies) and Clinical (i.e., human studies) biosimilarity studies.
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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