Biosimilar Testing and Development Services
A biosimilar drug is a biological medicine that is highly similar to a reference product with no clinically relevant differences in terms of safety, purity and potency. The demand for biosimilars is increasing as the patent cliff for many blockbuster biologics approaches. The emergence of biosimilars in the biologics drug market is set to improve patient access to life-saving drugs for serious diseases such as cancer and auto-immune diseases.
Demonstrating biosimilarity to the innovator product is a complex process. Our expert scientists have extensive experience in biosimilar analysis and testing services for the global biopharmaceutical industry. We offer an integrated service to support biosimilar development starting with innovator sourcing, cell line development, upstream process development, off-the-shelf biological analysis, physicochemical and structural analyses, cell bank characterization and cell bank manufacture.
Advance your biosimilar development programs with our expert team of scientists:
- Supported over 230 biosimilar development projects
- Worked with >50 biosimilar developers worldwide
- Industry leading portfolio of off-the-shelf cell based bioassays and binding assays
- Combined functional and physicochemical/structural analysis
- Integrated biosimilar development service offering from DNA to Clinic
Our experienced team have developed a suite of off-the-shelf assay packages to support biosimilar comparability and characterization to complete similarity studies for a range of biosimilar molecules:
- Actemra (tocilizumab) biosimilar testing
- Avastin (bevacizumab) biosimilar testing
- Enbrel (etanercept) biosimilar testing
- Herceptin (trastuzumab) biosimilar testing
- Humira (adalimumab) biosimilar testing
- Lucentis (ranibizumab) biosimilar testing
- Prolia (Denosumab) biosimilar testing
- Remicade (infliximab) biosimilar testing
- Rituxan/Mabthera (rituximab) biosimilar testing
- Simponi (golimumab) biosimilar testing
- Stelara (ustekinumab) biosimilar testing
Contact our biosimilar experts to discuss your project today.
Our R&D scientists continually develop new off-the-shelf methods to support biosimilar characterization and comparability. We are currently developing off-the-shelf assays for the following molecules:
- Erbitux (cetuximab)
- Eylea/Zaltrap (afilibercept)
- Orencia (abatacept)
- Synagis (palivizumab)
- Tysabri (natalizumab)
- Xolair (omalizumab)
- Yervoy (ipilimumab)
If you are working on a molecule that is not on our list then please contact us to discuss your specific requirements.