Clinical Trials

The development of a biosimilar begins with testing of the reference product to identify the critical quality attributes necessary for biological function, efficacy and safety. Once the reference biologic has been assessed, the manufacturing process for the proposed biosimilar is designed to generate a product with highly similar critical quality attributes. Testing is conducted to collect data to demonstrate biosimilarity between the proposed biosimilar and the reference product.1-2 This includes: 

  • Comprehensive comparison of the quality attributes of the proposed biosimilar compared to the reference product
  • Generation of comparative nonclinical and clinical data
  • Detailed analysis of the totality of data

Clinical testing is designed to identify any clinically meaningful differences between a proposed biosimilar and the reference product. The testing can include comparative pharmacokinetic, pharmacodynamic, efficacy, safety and immunogenicity testing.3 

Once the totality of evidence has been collected and reviewed, the regulator can evaluate whether the biosimilar candidate is highly similar to the reference biologic, and whether there are no clinically meaningful differences in terms of safety, purity and potency.3

To see how clinical trials are designed, watch the video below:


  1. Vulto-Jasquez. Rheumatology. 2017;56:iv14-iv29.
  2. Markus, et al. BioDrugs. 2017;31:175-187.
  3. USFDA. Scientific considerations in demonstrating biosimilarity to a reference product. 2015.Page Break