Biosimilars

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • Course Run Time: 65 minutes
  • Course Level: Level 3 - Advanced
  • Completion Period: 2 week

Biosimilars explain the science, manufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. Beginning with an overview of protein structure, function, and production, the class hones in on different types of biologics and how each mitigates disease. The manufacturing section highlights how conditions can alter a biosimilar, causing it to function differently than its reference product. The safety and regulation section examines immunogenicity and approaches to demonstrating biosimilar safety and efficacy that have been acceptable to the FDA and EMA. The class ends with four case studies that demonstrate the real-world complexity of biosimilar science, manufacturing, and regulatory challenges.

Suggested Prerequisites

The Biology of Biotech

Takeaways
  1. Understand how a biosimilar's structure dictates its function.
  2. Discuss how post-translational modifications can change a protein’s intended function.
  3. Learn how biosimilars may differ from their reference product due to the manufacturing process.
  4. Explain FDA and EMA requirements for biosimilar approval and the underlying scientific, quality, and
    regulatory principles involved.
  5. List 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
Trailer
Section 1: Proteins
Understand how a biosimilar's protein structure dictates its function.
Section 2: Biologics
Understand the characteristics of biologics/biosimilars.
Section 3: Biosimilars
Understand how biosimilars are designed and what is meant by "The product is the process."
Section 4: Manufacturing
Learn how biosimilars may differ from their reference product due to the manufacturing process.
Section 5: Safety and Regulation
Learn the FDA and EMA requirements for biosimilar approval and the underlying regulatory principles involved.
Section 6: Biosimilar Case Studies
Review four real-world case studies to better understand the challenges and rewards of producing biosimilars.
Final Quiz
You have 20 minutes to take this timed quiz. You have two attempts to pass the quiz with a 70% or higher grade.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
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.

Our online classes 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 to complete the class evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. 

There are no refunds once you have purchased an online course. 

The online classes 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 class 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 only when all three of these items are completed. 

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. 

 

BIO member discounts are available for on-demand, online classes. To access the BIO member discount, use your company email address during the checkout process. The checkout system will automatically recognize your organization and apply the 20% discount to your purchase if your company is a member of BIO. If you use a private email address we are unable to provide you the BIO membership discount.

If your on-demand course expires, but you have not completed it, you can extend it for an additional 2 weeks for $25.

  • Log into your dashboard
  • Go to the on-demand course you want to extend
  • The "Course Extension" button brings you to the payment gateway
  • Please note: It will appear you are being asked to pay the full amount of $150, but a discount will be automatically given once you fill in all of your payment information. 

You have 90 days, from the day your course expires, to take advantage of this nominal extension fee. Once the 90 days are past, you will need to pay the full price to view the course again. 

  1. Once your online course starts click on “Resources” in the upper right-hand corner
  2. In the drop down menu find the link “Course Slides”
  3. Download and/or print 
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent