Biosimilars

Bringing life-impacting biologic medicines to patients.

Coherus’ ultimate goal is to bring life-impacting biologic medicines to patients through innovation and access – whether commercializing biosimilars or developing novel immuno-oncology therapeutic combinations. We are building a leading oncology company backed by in-house expertise and an established infrastructure from our diversified portfolio of FDA-approved biosimilar products.

For more than a decade, Coherus has built a biosimilars business across multiple disease areas to provide physicians and patients the power of choice – the ability to choose access to high-quality, affordable therapeutics. We currently market two biosimilar products: UDENYCA® (oncology) and YUSIMRY (immunology).

We are building a leading oncology company backed by in-house expertise and an established infrastructure from our diversified portfolio of FDA-approved biosimilar products.

To meet the challenges of biosimilar development, we’ve built a scientific platform that incorporates cutting-edge analytics, immunology, clinical and regulatory expertise, and process and manufacturing quality. We believe this platform has been essential for our success in developing biosimilars, and we are applying key aspects of the platform 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.

Our current portfolio of approved biosimilars includes: UDENYCA® (oncology) and YUSIMRY (immunology).