Biosimilar development programs are designed in accordance with U.S. Food and Drug Administration (FDA) guidance and with the agency’s advice and feedback.
The goal of a biosimilar development program is to demonstrate biosimilarity with no clinically meaningful differences between a proposed biosimilar product and the reference product.
In 2018, Coherus successfully launched UDENYCA® (pegfilgrastim-cbqv), a biosimilar to Neulasta® (pegfilgrastim).Learn more about UDENYCA®
Reference biologics and biosimilars are scrutinized through different lenses. With reference biologics, the regulatory emphasis is on the results of clinical trials to demonstrate safety and efficacy for a given indication. With biosimilars, the emphasis is on demonstrating that there are no clinically meaningful differences from the reference drug in areas including safety, purity, and potency.
1 How does a manufacturer demonstrate biosimilarity? Biosimilars Resource Center. Accessed May 19, 2020. https://www.biosimilarsresourcecenter.org/faq/how-does-a-manufacturer-demonstrate-biosimilarity/
2 Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. US Food and Drug Administration. Published April 2015. Updated April 24, 2020. Accessed May 19, 2020. https://www.fda.gov/media/82647/download