BIO Professional Development

Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth

Biosimilars Primer

Biosimilars Primer explains the science, manufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. Beginning with an overview of protein structure, function, and production, this class hones in on different types of biologics and how each fights disease. This class highlights how production conditions can alter a biosimilar, causing it to function differently than its reference product. The course ends with a Safety and Regulation section that examines immunogenicity and approaches to demonstrating biosimilar safety and efficacy that have been acceptable to the FDA and EMA. Four real-world case studies illustrate the complexity and versatility of biosimilars in treating various medical conditions. Enroll today! 

Woman at a table using a laptop

Takeaways

  1. Discuss how post-translational modifications can change a biosimilar's intended function.
  2. Conclude how biosimilars may differ from their reference product due to the biomanufacturing process.
  3. Justify the EMA's and FDA's Totality-of-the-Evidence requirements for biosimilar approval and the underlying scientific, quality, and regulatory principles involved.
  4. Emphasize the rigorous safety standards required in clinical trials due to the potential of biosimilars triggering immunogenicity.
  5. Analyze real-world case studies to understand the complexity and versatility of biosimilars in treating different medical conditions.
Course Price:
$190 USD
BIO Member Price:
$160 USD
Course Length:
65 minutes
Course Level:
Intermediate
Completion Period:
1 year from date of purchase
Course Format:
On-Demand

Certificate Requirements

Complete the course quiz with a passing score of 75% or higher

Suggested Prerequisites
FLIP

Gain a comprehensive understanding of DNA, proteins, and cells, explaining how they are manipulated to create innovative therapies and diagnostic tools.

Professional Certificate
Related Courses
FLIP

Dive into antibodies' versatile role in research & clinic. Explore monoclonals, diagnostics, & more. Enhance fluency in antibody science.

Professional Certificate
FLIP

Dive deeper into immune systems: nonspecific & specific. Learn disease origins & immune responses for comprehensive understanding.

Professional Certificate
FLIP

Explore how the immune system combats diseases. Learn about pathogens, white blood cells, and biopharma's immune-based therapies."

Professional Certificate
FLIP

Explore foundational science of genetic modification -- the impetus for the creation of the biotechnology industry in the 1980s.

Professional Certificate