In order to meet the challenges of biosimilar development, we developed a scientific platform that incorporates cutting-edge analytics, clinical and regulatory expertise, and process and manufacturing quality. We believe this platform has been essential for our success in developing biosimilars, and that key aspects of the platform will confer benefit to our immuno-oncology program.
Developing biosimilars requires significant analytical work to characterize the reference product. Diverse competencies are called into play, including the ability to identify the reference product's critical quality attributes.
We have efficiently designed and executed clinical studies to align with the latest regulatory guidance to demonstrate biosimilarity. Strong interactions with the Food and Drug Administration are needed to provide clarity throughout the drug approval process.
Coherus takes bench-scale processes and transforms them into commercial-scale operations that make enough product to meet market demand while maintaining the individual product characteristics of the reference product. Coherus manufactures UDENYCA® (pegfilgrastim-cbqv) in Boulder, Colorado.