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Pre-Conference Workshop on
Systematic study on the chemical constituents, quality analysis and bioactivities of Polygala species
October 27-29, 2014 Hyderabad International Convention Centre, Hyderabad, India
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Theme: Biosimilars in Emerging Markets: Regulatory Considerations
Workshop Objectives:
- To provide an overview of regulatory models for evaluating similar bio therapeutic products ( Biosimilars) that are currently in place, or under development: perspectives of regulatory authorities, industry and clinicians.
- To discuss the quality, safety and efficacy factors that need to be considered to ensure patient safety when registering similar bio therapeutic products ( Biosimilars).
- To discuss complexities in evaluating quality, safety and efficacy of biologicals in general to ensure patient safety.
General Principles For Biosimilars:
- Key purpose of bio similarity studies
- Biological products being considered for bio similars.
- Reference biological product comparators.
- Scientific approach required – stepwise and totality of evidence.
Biosimilarity Step 1: CMC Comparability:
- Challenge of being blinded to innovator's CMC development
- Fingerprint, state-of-the-art protein characterization.
- Limitations of CMC similarity.
- Justifying observed CMC differences.
Biosimilarity Step 2: NONCLINICAL Comparability:
- Linkage to CMC biosimilarity findings
- Risk-based stepwise approach to Nonclinical comparability.
- Key elements of the Nonclinical biosimilarity study.
- Which Nonclinical studies are not needed for biosimilars.
Biosimilarity Step 3: CLINICAL Comparability:
- Linkage to both CMC and Nonclinical biosimilarity findings.
- Risk-based stepwise approach to Clinical comparability.
- Pre-defined acceptance criteria for human PK studies.
- Equivalence vs non-inferiority Clinical study design.
Biosimilar Lessons Learned and the Future:
- Successful EMA marketed biosimilar products
- Status of FDA biosimilar products in clinical development.
- EMA biosimilar successes and failures.
- Crystal-balling – price reductions, biosuperior .
Following are some of the questions which are most commonly faced by Biosimilar Manufacturers which would be answered during the workshop
- How similar is similar? What is likely not to be accepted by the regulator?
- Comparability studies: Regulatory guidance on how to practically carry out comparability studies and prove comparability to the regulator?
- Immunogenicity: How should immunogenicity be reported? How can key concerns and risk be measured and effectively addressed?
- Extrapolation of indications: How do regulators justify doing extrapolation?
- How do the regulators handle biosimilar applications from industry and what is the experience here?
- What is the regulatory advice on a stepwise approach for achieving approval, including the analytical package and clinical testing?
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