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
