Biosimilars

ICON can support product design, development and registration, regulatory support and commercialisation.

Biosimilars


Biosimilars (or Follow on Biologics) are protein therapeutics that are intended to be substitutable for existing branded biologic products. Because true replication of the existing protein drug cannot be established the term “biogenerics” is not appropriate for these products. Hence the use of the term “biosimilars”.

ICON can support the complete development of Biosimilars/Follow-on Biologics. We have the required expertise to assist in product design, development and registration, regulatory support and commercialisation. Our portfolio includes:

Strategic Planning and Design

  • Product portfolio reviews
    • Current products, indications and associated exclusivities
    • Competitive landscape / Future market assessment 
  • New Product Concepts
    • Due diligence for product acquisition
    • Product Development Planning:
      • Strategic development options to Proof of Concept, Regulatory Submission or other development milestones
      • Issues assessment and mitigation strategies
      • Nonclinical/Clinical development strategies
      • Regulatory enabling strategies, including scientific advice and pediatric plans

Product Development Capabilities

  • Non-clinica/Preclinical development
    • In vitro studies
    • In vivo studies
  • Bioanalytical
    • Non-clinical and clinical assay support
    • PK assays for comparability testing v Approved Biologics
    • Immunogenicity testing
    • Biomarker assays
  • Non-clinical development, Drug Quality
    • Physico-chemical testing
    • Drug substance and drug product comparability
    • Formulation development and characterization
    • Stability testing
  • Clinical efficacy and safety
    • PK/PD assessments including comparison to reference products
    • Ph I-IV studies
    • Risk Management Planning

Regulatory Support Services

  • Lifecycle Support
  • Submissions to CAs, (CTAs, MAAs NDAs etc)
  • New Indications/ Label extensions and changes
  • Annual reporting
  • PIL Testing
  • DMAC services

Commercial and Marketing Services

  • Patent advice
  • Pricing and reimbursement
  • Preparation of AMCP dossiers
  • Marketing materials & Medical communication
  • Pharmacovigilance support, Risk Management plans
  • Out-licensing support