Biosimilars


ICON supports method development, GCP/GLP compliant biosimilar assay validation and sample analysis for PK and immunogenicity/anti-drug antibody (ADA) testing.  Our approach follows industry best practices and regulatory guidance’s.

To ensure a true assessment of comparability between the originator and the biosimilar, standardisation of PK and immunogenicity assay formats is essential.  ICON's Bioanalytical Laboratory advocates the use of a single PK assay to quantitate both the originator and biosimilar.  

Based on our experience of supporting biosimilar programs for diverse compounds and indications, we also recommend early and frequent communication with regulators to identify the appropriate immunogenicity approach.

 

Extensive experience  

Our Bioanalytical Laboratory has provided support for the following 11 biosimilar programs since 2012 and has experience with regulatory filings in the US, Europe and Korea. 

• Abatacept
• Adalimumab
• Bevacizumab
• Cetuximab
• Etanercept
• Infliximab
• Omalizumab
• Pegfilgrastim
• Ranibizumab
• Rituximab
• Trastuzumab

Using our depth of expertise in assays for biologics, we also have validated several ICON proprietary bioanalytical methods for the innovator products listed below.  These have been used to support biosimilar programs, standard of care and combination therapy testing, and leveraged to  support assays for preclinical development programs.

• Adalimumab
• Bevacizumab
• Cetuximab
• Etanercept
• Infliximab
• Peginterferon alfa-2a
• Rituximab
• Trastuzumab

Supplementary validation testing is required to qualify biosimilar compounds into the assays and may also be necessary depending on therapeutic area. In addition to the validated assays, we have developed assay formats for several innovators that are available and can reduce time to sample analysis.


Proven quality

In a recent 2015 FDA pre-approval inspection of our bioanalytical biosimilar work, no ‘483’ was issued and the inspection results supported the marketing approval of a biosimilar in the US.

 

Contact us now to discuss the details of your program with Scientists who understand the challenges and can advise on strategies for success.