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The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA
Course Summary
The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.
We describe the provisions of the Biologics Price Competition and Innovation Act, identify criteria for licensing a follow-on biologic as ‘biosimilar’ or ‘interchangeable’, specify periods of market exclusivity that apply, and discuss patent infringement issues.
Finally, we describe the provisions of the Biosimilar User Fee Act, which authorises the FDA to collect fees from follow-on biologics sponsors, to support review activities.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Outline the provisions of the Biologics Price Competition and Innovation Act
• Identify criteria for licensure of a follow-on biologic as biosimilar or interchangeable
• Specify periods of market exclusivity applicable to biological medicinal products
• Outline patent infringement issues relevant to biological medicinal products
• Access FDA guidance on development and licensure of follow-on biologics
• Outline the provisions of the Biosimilar User Fee Act
Who will benefit from this course
This module will mainly benefit regulatory affairs staff concerned with the licensure of follow-on biological products.
Module Outline
• Assessment
Multiple-choice mastery assessment
Roles
Regulatory
CPD Points
0.5
Region
Level
Introductory/Intermediate
Course Study Time
Approx 30 minutes
USA