SMi Source Lesson Biotech: Biosimilars

  • 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