BioPharma Services >> Bioanalysis >> Biosimilars


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As patents on many major biologics are expected to expire by 2016, it's estimated that roughly half of the large molecule therapeutics market, representing an estimated $92B in 2010, will be open to competition from large molecule generics, often referred to as biosimilars or follow-on biologics.

Over 50 biosimilars/copy-biologics, covering a fairly limited selection of branded drugs, are in the clinic. However, most of these are restricted to emerging markets. Comparatively, only 14 biosimilar approvals have occurred in Europe and none in the United States. It is expected that biosimilar development in these markets will accelerate driven by the emergence of regulatory guidelines, the impending patent cliff and the push for cheaper medications. 

Industry Leading Biosimilars Experience

With our regulatory knowledge and experience in product characterization, pharmacokinetics and immunogenicity, for both innovator and biosimilars, we carry your project from Discovery phase through Phase III studies and beyond.

Pre-qualified Assays

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Biosimilar Assay Development & Testing    

A diverse set of methods to evaluate comparability of both the biosimilar drug and it's clinical performance. Eurofins Bioanalytical Services develops  customized assays for the comparability testing of biosimilars, exploratory or GLP, including: 

Clinical Assays

  • PK assay
  • Tiered Immunogenicity (Anti-Drug Antibodies, ADA) testing
  • Nab assays

Comparability testing    

  • Effector binding Biacore (Surface Plasmon Resonance, Biacore)
    • FcγRI (CD64)
    • FcγRII (CD32a)
    • FcγRIII (CD16a)
    • FcRn
  • C1q binding by ELISA
  • Kinetic binding assays by Biacore
  • ADCC & CDC assays cell-based assays

Biosimilars Service Highlights

  • 9 years of bioanalytics experience, including 4 years in biosimilars
  • Regulatory compliant labs in US and EU
  • Experience with monoclonal antibodies, metabolic hormones and immunomodulatory drugs
  • Method transfer / method development & validation / Routine sample analysis
  • Delivery of high quality data suitable for regulatory submission 

Expertise in simple and complex biosimilars

Biologic type

Generic name

Product Characteriztion



Small, Non-glycosylated protein
Small, Non-glycosylated protein
Small, Non-glycosylated protein
Insulin Lispro
Small, Non-glycosylated protein
Insulin Glargine
Small, Glycosylated protein
Epoetin alpha
Monoclonal antibody

Monoclonal antibody

Monoclonal antibody
Monoclonal antibody
Monoclonal antibody
Monoclonal antibody