SMi Source lesson Biotech: Biosimilars has the following microlearning topics
1. Introduction to Biosimilars
2. Biologics and Protein Therapeutics
3. Biologics Overview
4. Modified Therapeutic Proteins
5. Modified Therapeutic Proteins Improve Function
6. Manufacturing Process
7. Biologics in the Marketplace
8. Knowledge Check: Characteristics of Small Molecule and Biologic Drugs
9. Knowledge Check: Identifying Biologic Drugs
10. Biosimilars Overview
11. Biosimilar Overview and Definition
12. Regulatory Milestones and General Requirements for the Production of Biosimilars
13. Biosimilars in the Marketplace
14. Benefits, Risks, and Patent Life
15. Benefits, Risks, Marketing, and Claims
16. Challenges in U.S. Marketplace
17. Examples of Biosimilars
18. Biosimilars Under Review
19. Example of a Biosimilar Not Approved by the EMA
20. Knowledge Check: Biosimilars are...
21. Knowledge Check: Approval of Biosimilars in the EU
22. Knowledge Check: Challenges in Marketing a Biosimilar Drug
23. Approval Process and Regulatory Pathways
24. Reference Product
25. Quality and Ingredient Requirements
26. Substitution and Interchangeability
27. Manufacturing and Production
28. Manufacturing Requirements
29. Allowable Differences Between the Biosimilar and the Reference Biologic
30. Evidence Generation: Non-Clinical
31. Evidence Generation: Clinical
32. Evidence Generation: Comparative Data
33. Hurdles to Approval
34. Pharmacovigilance and Risk Management
35. Summary: Stepwise Approach to Establish Biosimilarity
36. Knowledge Check: Biosimilar Attributes
37. Knowledge Check: Ligand Binding Assays, Enzymatic Assays, and Functional Assays Testing Use
38. Knowledge Check: Biosimilar Drug Interchangeability
39. Knowledge Check: Roles of a Pharmacovigilance Program
40. Introduction to Country-Specific Definitions and Regulatory Guidelines
41. World Health Organization (WHO)
42. European Medicines Agency (EMA)
43. European Medicines Agency (EMA) Detailed Requirements
44. Food and Drug Administration (FDA) Detailed Requirements
45. Japanese Ministry of Health, Labour and Welfare (MHLW)
46. Health Canada
47. South Korea Ministry of Food and Drug Safety (MFDS)
48. India Ministry of Science and Technology (MST)
49. Summary of Country-Specific Definitions and Regulatory Guidelines
50. Knowledge Check: Terms Used in Different Countries
51. Knowledge Check: EMA Centralised Authorisation Procedure
52. Knowledge Check: Approving Biosimilars Since 2000
Lesson Biotech: Biosimilars teaches these concepts
Introduction, Introduction to Biosimilars