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Clinical and Regulatory Expertise

In order to increase the likelihood of product approval, companies look to partner with the US FDA and other regulatory agencies to understand their requirements on a product-by-product basis. Strong interactions with the agency provide clarity about the elements required to establish biosimilarity, and what they want to see in the clinical package.

With the knowledge that Coherus gains from these interactions, we efficiently design and execute studies to align with the latest regulatory guidance to demonstrate biosimilarity.

Scientist working in a lab
Presentation showing the process for demonstrating biosimilarity