Course
The Regulatory Pathway to Approval of Follow-on Biologics (Biosimilars) in the USA
$349 USD
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Learn about the regulatory pathway to approval of Follow-on Biologics (Biosimilars) in the US.
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Summary
Biological medicinal products are subject to regulations and laws established in recent years. Biologics present a challenge because the reproduction of effective therapeutic proteins is more difficult than generic drugs. As a result, biologics have certain provisions that must be met/adhered to as per the Biologics Price Competition and Innovation Act.
Learn:
- How to access FDA guidance on the development and licensure procedure for follow-on biologics.
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About the Biologics Price Competition and Innovation Act
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Biosimilarity and interchangeability
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The criteria for biosimilar licensure