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Held in conjunction with Biomarkers - From Research To Commercialization
12 Dec 2017 - 13 Dec 2017, at 9:00 AM - 5:00 PM in Bengaluru
The biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product - BIOSIMILAR. A biosimilar product must have comparable levels of efficacy and safety to the original product to be approved on an accelerated timeline; the only differences allowed are in non-active ingredients or components. FDA requires licensed biosimilar and interchangeable biological products to meet the Agency’s rigorous standards of safety and efficacy. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product. The demonstration of ‘similarity’ between the approved product and the proposed product (Test) often warrants type and amount of analyses and testing sufficient to demonstrate biosimilarity which is more than often based on product-specific requirements and attributes posing numerous challenges in devising a clinical development plan. Statements regarding bioavailability and bioequivalence appear to be simple and straightforward, however, have given rise to considerable controversy in pharmaceutical and clinical circles for many years which are compounded by economic factors associated with establishing biosimilarity. Numerous rules and global regulations have been issued and equal, if not more, number of interpretations and opinions have been reported primarily due to our insufficient understanding of the scope and depth of fundamental considerations associated with pharmaceutical as well as clinical development plan. Challenges, more than often, surface while designing investigations – clinical and non-clinical – that would meet the nebulously defined, if not product specific, criteria to satisfy the demonstration of ‘similarity’ and ‘totality of evidence’. To address such challenges, one has to adopt an ‘out of the box’ approache(s) that are scientifically sound and are convincing and compelling. This 2-day intensive program presents global perspectives – regulatory and technical – addressing the various challenges in designing, conducting and presenting successful clinical development program including providing satisfactory and convincing rationale for queries from various regulatory agencies post submission of results/data through a judicial blend of technical information and case studies Topics to be Covered - BIOSIMILARS: Fundamentals and Comprehensive understanding
- BIOSIMILARS: Understanding the Development Path
- BPCI Act and Section 351(k) of PHS
- Demonstration of Similarity
- Totality of Evidence/Information
- Clinical Study Design Issues
- Global Regulations: Requirements versus Expectations
- PK-PD combination CTs - Role and Significance
- Case Study(ies)
Agenda
Day 1
Session I- Introduction, course objectives
- Definitions and Terminologies
- Biosimilars vs Generics: Fundamentals and comprehensive understanding
Session II- BIOSIMILARS: Understanding the Development Path
- Factors to consider
- Interchangeability: Meaning and Application
- Similar vs Equivalent: Who decides !!!!
- Regulatory Understanding and Acceptance
Session III- BPCI Act and Section 351(k) of PHS
- Demonstration of Similarity
- Totality of Information: Meaning, Interpretation and Application
- Clinical Trials: Scope and Limit
- Regulatory Guidance(s) – Applicability and Acceptance
- Regulatory Considerations: Requirements versus Expectations
- IP Considerations: The Patent Dance
Session IV- Totality of Evidence
- Development Plan: Scope and Extent
- Structural and Functional Characterization
- Clinical Knowledge and Awareness
- Human PK and PD: Understanding and Demonstration
- Non(human) Clinical studies: Role of Animal studies data
DAY 2
Session V- Demonstrating Similarity: Part I
- Human Pharmaological data
- Clinical Immunogenicity Assessment
- Clinical Safety and Efficacy Data
- Case Study I
Session VI- Demonstrating Similarity: Part II
- Clinical Study Design Issues
- Extrapolation of Clinical Data Across Indications
- Non-US Approved Comparator: What to do/can be done !!
- Guidance on Biosimilars: FAQs and As
- Case Study I (contd.)
Session VII- IVIVC/IVIVR/IVPT in Biosimilars drug development
- PK-PD combination CTs - Role and Significance
- Case Study
Session VIII- Beyond Demonstrating Bio-similarity !!
- Addressing Regulatory Queries
- Case Studies
Section IX- Summary and Concluding Remarks
- Questions and Answers
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 Umesh Banakar, Professor and President, Banakar Consulting Services
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