Biosimilars

BSSI supports clients throughout the testing and development of biosimilars. With broad experience in this highly diverse field, BSSI is well versed in the distinct requirements for these products.

  • Experimental study design
  • Analytics for screening, optimization and validation
  • Assay analytics including validation
  • Equivalence testing
  • Clinical protocol and study design, including sample size determination and randomization
  • Statistical analysis plans
  • Results reports including summary of safety and efficacy findings