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SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA

SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA

  • 30 Day Money Back Guarantee
  • Completion Certificate
  • 24/7 Technical Support

Highlights

  • On-Demand course

  • 30 minutes

  • Intermediate level

Description

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

About The Provider

Zenosis
Zenosis
Dundee
We specialise in Pharmaceutical & Biotech courses for healthcare professionals, as well as a suite of essential courses for regulatory and statutory business compliance. As a member of the CPD, you can be assured that our courses meet exacting standards and deliver a compelli...
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