Reach the market faster and with greater probability of success
INCREASE THE VALUE OF YOUR BIOSIMILAR
Assess Biosimilarity Sooner – With innovator-specific Biosimilar CMC Analytical Master Files containing
pre-established methods and preliminary reference data


Make Better Decisions – Through rigorous and comprehensive testing methodologies developed to enable early and thorough assessment of biosimilarity

Smarter Advancement – Via a phase-appropriate, molecule management approach with the development and product lifecycle in mind

Four Options – Provide you flexibility wherever your biosimilar is in the development or product lifecycle: 
  • Testing solutions
  • Evaluation of your data
  • Consultative insights
  • Access to methods and data
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Covance Biosimilar CMC Analytical Master Files are unique guides and the foundation for risk-mitigated biosimilarity assessment, biosimilar testing and client data evaluation. 14 marketed innovator targets have pre-established CMC Analytical Master Files completed, in development, or planned.
BIOSIMILAR CMC ANALYTICAL MASTER FILES & DEVELOPMENT SOLUTIONS