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Bio Online Course

Biotherapeutics Online Course

This online course provides basic knowledge on essential elements of Biotherapeutics.
Each lecture was developed using training materials from previous AHC workshops & CoE Pilot trainings, and categorized into 5 Parts.



  • Course Guide:
    •   ◎    This online course provides trainings on Biotherapeutics in 5 Parts.
               Please click on each part to select topics of interest.
    •   ◎    Each lecture offers videos in two (2) different resolutions (HD/Low).
               Please select the version of your choice.
    •   ◎    Related guidelines (PDF) for each topic will be shown for your reference
               when you click the  button. Please click on each icon to view the file.
  • Video lecture
    PART I: Current Status of Global Regulatory Framework and Harmonization
    Title Video Lecture
    HD / Low
    Time Guideline
    Subject 1) Overview of Biotherapeutics and a Roadmap Toward Convergence
    1-1 Biologics vs. Small Molecule Pharmaceuticals   20m 45s
    1-2 Current Development/Regulatory Strategies of Biotherapeutic Products
    - Key Points to Consider vs. Small Molecules
      View More22m 29s
    Related Guideline
    Title Summary PDF
    ICH Q5A(R1) Viral Safety Evaluation of Biotechnology Products Decrived from Cell Lines of Human or Animal Origin
    ICH Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products
    ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechological/Biological Products
    ICH Q5D Derivation and Characterisation of Cell Substrates used for Productino of Biotechnological/Biological Products
    ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
    1-3 Readout of the RHSC Biotherapeutics Roadmap
    - Regulation of Biotherapeutics and its    Implementation in APEC economies
      View More15m 16s
    Related Guideline
    Title Summary PDF
    ICH Q5A(R1) Viral Safety Evaluation of Biotechnology Products Decrived from Cell Lines of Human or Animal Origin
    ICH Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products
    ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechological/Biological Products
    ICH Q5D Derivation and Characterisation of Cell Substrates used for Productino of Biotechnological/Biological Products
    ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
    ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
    ICH S6(R1) Preclinical Safety Evaluation of Biotechnology-Dericed Pharmaceuticals
    1-4 Evaluation of Biotherapeutics: From WHO Guidelines to their Implementation
    - Regulation of Biotherapeutics and its    Implementation in APEC economies
      29m 42s View More
    Related Guideline
    Title Summary PDF
    WHO Guidelines (Public Consultation) WHO Guidelines on the Quality, Safety, and Efficacy of Biotherapeutic Products Prepared by Recombinant DNA Technology
    WHO Guidelines Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)
    Subject 2) Current Status of Biosimilar Global Regulation
    2-1 Rapid Evolution of Biosimilar Regulation   28m 34s View More
    Related Guideline
    Title Summary PDF
    EMA Guideline Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance
    : non-clinical and clinical issues
    2-2 WHO Activities and Updates in the Area of Biosimilar   15m 28s View More
    Related Guideline
    Title Summary PDF
    WHO Drug Information 16th International Conference of Drug Regulatory Authorities (ICDRA) Recommendations
    WHO Guidelines (Public Consultation) WHO Guidelines on the Quality, Safety, and Efficacy of Biotherapeutic Products Prepared by Recombinant DNA Technology
    2-3 Establishment of Biosimilar Guideline in China   19m 17s
    2-4 Comparison of Biosimilar Guidelines   21m 03s View More
    Related Guideline
    Title Summary PDF
    MFDS Guidelines Guidelines on the Evaluation of Biosimilar Products
    Health Canada Guidance Document Information and submission Requirments for Subsequent Entry Biologics
    WHO Guidelines Guidelines on evaluation of similar biotherapeutic products (SBPs)
    EMA Guideline Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance
    : non-clinical and clinical issues
    PMDA Guideline Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics
    US FDA - Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
    2-5 Biosimilar Regulations - United States   44m 55s View More
    Related Guideline
    Title Summary PDF
    U.S.FDA - Guidance for Industry Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants Guidance for Industry
    US FDA - Guidance for Industry Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
    US FDA - Guidance for Industry Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
    US FDA - Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product