TFS Biosimilar Expertise

TFS offers a full service portfolio to meet the projected expansion of the biosimilar market.

With a dedicated, multi-disciplinary team of experts, TFS provides high value services for the design, development and conduct biosimilar clinical trials. TFS expertise combined with advanced processes reduces the development timeline of a biosimilar portfolio from early phase to phase III registration trials.

Our services include:

Biosimilar comparability trials

  • Strategy and content of biological product development program
  • Stepwise Approach, Totality of Evidence Approach
  • Clinical trial design (equivalence, non-inferiority against the off-patent biological)

Regulatory approval pathway for biosimilars

  • Regulatory and scientific guidelines
  • Regulatory environment in Europe and the US
  • Product dossier format and content
  • Product application to Regulatory Authorities
  • Responding to questions from Regulatory Authorities

Scientific Advisory Meetings with Regulatory Authorities

Access to patient populations, rapid patient recruitment and retention

Clinical Monitoring

Safety/Pharmacovigilance consultation

Biostatistics

  • Selection of endpoints to demonstrate comparability
  • Statistical analysis

Reporting of Results

  • Clinical Study Reports
  • Scientific publications, abstracts