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!
Section 1: Proteins
Understand how biosimilars 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.
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Five Takeaways
- Discuss how post-translational modifications can change biosimilars’ intended function.
- Conclude how biosimilars may differ from their reference product due to the biomanufacturing process.
- Justify the EMA’s and FDA’s Totality-of-the-Evidence requirements for biosimilar approval and the underlying scientific, quality, and regulatory principles involved.
- Emphasize the rigorous safety standards required in clinical trials due to the potential of biosimilars triggering immunogenicity.
- Analyze real-world case studies to understand the complexity and versatility of biosimilars in treating different medical conditions.
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Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
FAQ
- How long do I have to complete an on-demand course? You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
- What happens if I don’t complete the course in one year? There are no time extensions. If you want to complete the course, you must purchase it again.
- How long are the on-demand classes? Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes. The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
- Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
- What is the format of the on-demand classes? The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
- Can I repeat the course? You can repeat the course as often as you like within your one-year access.
- How many times can I take the course quiz? You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
- May I share a course I purchased with others? Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.