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Biosimilars provides an overview of the science, biomanufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. The course begins by taking an in-depth look at the science, specifically how a therapeutic protein’s structure dictates its function. With this foundational knowledge, users understand how biomanufacturing conditions can alter a biosimilar, causing it to function differently than its reference product. The course ends with various tested approaches to demonstrating biosimilarity that have been acceptable to the FDA and EMA.

Biosimilars Course Trailer


  • Describe how a protein’s structure dictates its function and how post-translational modifications can change a protein’s intended function.
  • Define the term biosimilar.
  • Discuss how biosimilars may differ from its reference product once it has been manufactured.
  • Explain the FDA and EMA requirements for approval of a biosimilar product and the underlying scientific/quality/regulatory principles involved.
  • Describe the general considerations of animal/clinical/in vitro studies, as well as the FDA’s Totality-of-the-Evidence approach.

Download Course Syllabus

Course Price:
$150 USD
BIO Member Price:
$120 USD
Course Length:
50 minutes
Course Level:
Completion Period:
2 weeks
Course Format:

Certificate Requirements

  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
Suggested Prerequisites

Understand the biopharma industry by focusing on cells, DNA, and proteins and how these are manipulated by researchers to develop new health care products.

Professional Certificate
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