SMi Source Lesson Diabetes: Insulin Biosimilars

  • SMi Source lesson Diabetes: Insulin Biosimilars has the following microlearning topics

  • 1. Introduction

    2. Overview: Biologic Medical Products

    3. Overview: Regulatory Definitions and Mechanism of Action

    4. Overview: Biologics vs. Small Molecule Drugs

    5. Production of a Recombinant Biologic

    6. Production of Monoclonal Antibodies

    7. Enhancement and Variation

    8. Biologics in the Marketplace

    9. Patent Cliff and Biologic Medicines in Development

    10. Knowledge Check: Small Molecule Drug vs. Biologic Medicinal Product

    11. Knowledge Check: Characteristics of Specific Drug Classes

    12. Knowledge Check: Example of a Post-Translational Modification

    13. Introduction and Definition: Biosimilars

    14. Demonstrating Biosimilarity: Challenges

    15. Demonstrating Biosimilarity: Comparative Pharmacokinetics

    16. Biosimilars in the Marketplace and Drug Development in the U.S.

    17. Biosimilars in the Marketplace

    18. Knowledge Check: Pharmacokinetic Parameters

    19. Knowledge Check: Biological Products

    20. Biosimilar Insulins

    21. Knowledge Check: 2012 EMA Draft Guideline on Development of Biosimilar Insulins

    22. Drug Patents and Generics

    23. European Medicines Agency (EMA)

    24. U.S. Food and Drug Administration

    25. U.S. Food and Drug Administration: Regulatory Oversight

    26. Knowledge Check: U.S. and U.K. Regulation of Biosimilars

    27. Summary: Biologics and Biosimilars