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
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?
Conference Secretariat