We've contributed to the approval of multiple biosimilar drugs, providing global clients with efficient, cost-effective analytical similarity study design and execution, while anticipating regulatory questions.

Our comprehensive internal databases and established testing strategies support biosimilar antibodies in development. Our stepwise characterisation approach begins with reviewing public data to select optimal methodologies, establishing a preliminary Quality Target Product Profile (QTPP), and defining Critical Quality Attributes (CQAs). We progressively conduct more complex head-to-head analytical similarity studies using robust, qualified methods.

Leveraging our immunology and bioanalytical expertise, we offer proprietary methods, generic platforms, and custom analytical development capabilities. These deliver high-quality data with a focus on sensitivity to structural attributes that influence biological activity, ensuring your products meet the highest standards of safety, efficacy, and regulatory compliance.

Biosimilar Experience

Choosing RoukenBio means partnering with experts committed to delivering high-quality, reliable data for your biosimilar characterisation needs. We’ve established testing packages and supported the release of numerous marketed biosimilars, offering comprehensive support throughout your development journey. We assist with method selection, CQA definition and detailed data interpretation, tailoring our services to your specific programme requirements.  Our advanced off-the-shelf methods, generic platforms, and custom development capabilities, coupled with our proactive approach to regulatory questions, ensure efficient progression of your development program. Leverage our experience in conducting analytical similarity studies across various biosimilar antibodies, including:

• Nivolumab: PD-1
• Pembrolizumab: PD-1
• Bevacizumab: VEGF-A
• Aflibercept: VEGF-A
• Palivizumab: F protein (RSV)
• Tocilizumab: IL-6R
• Etanercept: TNFα
• Adalimumab: TNFα
• Infliximab: TNFα
• Golimumab: TNFα
• Denosumab: RANKL
• Rituximab: CD20
• Ocrelizumab: CD20
• Trastuzumab: Her2
• Pertuzumab: Her2
• Ustekinumab: IL-12/23