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Following the Established FDA Approval Process

Biosimilarity is demonstrated through analytical, nonclinical, and clinical studies.

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®

Understanding the differences between biologics and biosimilars.

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.

The FDA Recommends a Stepwise Approach for Biosimilar Development

Biosimilar process pyramid
  • Demonstrate safety and effectiveness with adequate and well-controlled substantial evidence for a new product.
  • FDA reviews the totality of data beginning with a foundation of detailed analytical characterization.
  • Comparative clinical studies are needed only if required by the FDA.


1 How does a manufacturer demonstrate biosimilarity? Biosimilars Resource Center. Accessed May 19, 2020.

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.