Biosimilars Primer

Biosimilars Primer
  • Level: Intermediate
  • CPE: 1.0 Credits
  • Time: 65 Minutes

Biosimilars Primer examines the development of complex biologic medicines, illustrating how minor manufacturing adjustments can impact performance and how regulatory agencies, such as the FDA and EMA, evaluate safety and efficacy. Real-world case studies demonstrate the impact of biosimilars in clinical practice.

  1. Learn how companies gain regulatory approval for a biosimilar
  2. Discover sources of variation between two manufacturing campaigns using identical inputs
  3. Explore immunogenicity and its implications for adverse reactions in patients receiving biosimilar treatments
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  • Overview
  • Agenda
  • Features
  • Justify This Training
  • FAQ

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Agenda

  1. Proteins

    Details the way protein structure influences the function of biosimilars.

  2. Biologics

    Lists the characteristics of biologics/biosimilars.

  3. Biosimilars

    Explains the design principles behind biosimilars and the concept that “the product is the process,” referring to the critical role of manufacturing in determining a biosimilar’s safety, purity, and efficacy.

  4. Manufacturing

    Explore the differences between biosimilars and their reference products, including variations in manufacturing and their potential safety implications.

  5. Safety and Regulation

    States the FDA and EMA requirements for biosimilar approval and the underlying regulatory principles involved.

  6. Biosimilars Case Studies

    Explore four real-world case studies to gain insight into the challenges and benefits of biosimilar production.

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

Justify This Training

View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.

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