Testing Biosimilars for FDA Approval

A marketing application for a biosimilar should be submitted under the 351(k) section of the Public Health Service (PHS) act. To prove biosimilarity, such an application must include information about analytical studies, animal data, and clinical studies. According to section 351(k) of the PHS act, analytical studies should “demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components.” Understandably, analytical studies should be an essential first step in a biosimilar development program.

Biosimilar Development at Pacific BioLabs

The bioanalytical laboratory at Pacific BioLabs can support biosimilar studies from start to finish, from initial characterization studies to stability studies to determine the shelf life of a biosimilar, and formulation support. Based on the reference product and its physicochemical and biological analysis, we will help you determine the best course of action for your proposed biosimilar.

Biosimilar Services Offered

  • Bioanalytical Method Development and Validation
  • Characterization of Starting Molecule and Final Drug Product
  • Elucidation of Post-Translational Modifications (such as glycosylation)
  • Identification and Characterization of Process Related Impurities
  • Immunogenicity Assays, Bioassays and Binding Assays
  • Stability Studies (e.g. forced degradation or accelerated)
  • Physicochemical and Biological Assessment of Reference Product

Analytical Instrumentation

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