Biosimilars

  • Course Price: $150
  • BIO Member Price: $120
  • Course Run Time: 50 minutes
  • Course Level: Level 2 - General
  • Completion Period: 2 week

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.

Suggested Prerequisites

Biology of Biotech

Takeaways
  1. Describe how a protein’s structure dictates its function and how post-translational modifications can change a protein’s intended function.
  2. Define the term biosimilar.
  3. Discuss how biosimilars may differ from its reference product once it has been manufactured.
  4. Explain the FDA and EMA requirements for approval of a biosimilar product and the underlying scientific/quality/regulatory principles involved.
  5. Describe the general considerations of animal/clinical/in vitro studies, as well as the FDA’s Totality-of-the-Evidence approach.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
Trailer
Protein Function
Reinforces a deep understanding of proteins by describing their various cellular functions through examples. Biosimilars are proteins.
Protein Synthesis
Explains protein structure and the steps involved in making a protein. By understanding that a protein's structure influences its functions, one can b...More
Post Translational Modifications
Points out that both genes and cells influence the type of post-translational modification and the degree to which the protein is modified. This modif...More
Biologics
Lists the functions of therapeutic proteins and compares and contrasts biologics with small molecule drugs.
Introduction to Biosimilars
Reviews the EMA and FDA definitions of biosimilars.
The Product Is the Process
Lists the steps of biomanufacturing explaining the goal of each step. This section identifies where variations can occur between two identical product...More
Biosimilars Safety and Regulation
Takes an in-depth look at immunogenicity, a main safety concern of biosimilars. A discussion of how companies test for immunogenicity and predict immu...More
Biosimilars Case Studies
Final Quiz
Course Evaluation
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
You have two weeks from time of purchase to complete any of the online courses. For example, if you purchase the course at 9 am on Saturday, the course will close at 9 am 14 days later.

You can pay an additional fee for an extension.

Our online courses are between 40 minutes and 85 minutes in length. We suggest allowing 20 minutes to take the end of the course quiz and 10 minutes for the course evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. You will be able to download the pdf once you have registered for the course. 

There are no refunds if you decide to not take the course once you have registered. 

The online courses are fully animated with a professional voice-over. Each course begin with an overview of what you will learn, the course itself, and then ends with a course quiz to assess your understanding.

You can repeat the course as often as you like within your two week run time.

You have two chances to pass the quiz. A passing score is 70% or higher. 

Each course is to be taken by one individual. If you would like to take our online courses as a group, please contact Stacey Hawkins at This email address is being protected from spambots. You need JavaScript enabled to view it. for pricing.

There are three requirements to receive your course certificate. 1. You must view the entire course. 2. You must pass the course quiz with a 70%. 3. You must complete the course evaluation. You can download and print your certificate from your dashboard.

Before moving on to the next section of our on-demand, online courses, all slides within a section must be viewed.

There is an easy way for you to see which slides you have completed and not completed in the course. Look at the menu on the left side of the course- the slides that have been seen are darkened and the slides that have not been seen are light. 

 

Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation