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Biosimilars and Interchangeables: What They Are and Why They Matter


Created on October 11, 2018



What in the world is a biosimilar? How does one get approval for one? Are interchangeable biosimilars really different? The area of biologics products, until recently thought of as "science fiction," are now the future of medical innovation. Along with these biologic products come biosimilars and interchangeable biosimilars, essentially alternative biologic product options to the innovator product.

What exactly are these products, how are these products performing in the marketplace, and what hurdles does one have to overcome to obtain licensure from the Food and Drug Administration (FDA)? Some of those answers are much more complex than you think. Seven of the top ten selling pharmaceutical products are now biologic products (with more to come, particularly with the FDA's newly released Biosimilars Action Plan).  

Get in the know with this program, led by attorneys Ha Kung Wong and John Kirkland, to understand the regulatory and IP impact of these products - and to be ready for the future.

Learning Objectives:

  1. Define "biosimilars" and understand the importance of Interchangeables
  2. Identify potential marketplace impact of biological products
  3. Recognize the current approval pathway for interchangeables
  4. Appreciate the recommendations and goals for FDA Guidances and the new Biosimilars Action Plan

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