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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 these studies from start to finish, from initial characterization studies to stability studies to determine the shelf life of a biosimilar. 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

  • HPLC
  • GC
  • GC/MS
  • LC/MS/MS
  • ELISA plate readers


FDA Draft Guidance, Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, February 2012

FDA Draft Guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, February 2012

ICH Harmonised Tripartite Guideline, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Intertek Logo PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek. AAALAC Logo Our animal science operations are accredited by AAALAC.

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