The Sandoz process demonstrates biosimilarity

Consistent with the FDA process for approval of biosimilars, the Sandoz development approach requires extensive testing to prove a biosimilar matches its reference biologic. Testing must ensure matching safety, purity, and potency, with no clinically meaningful differences from the reference biologic, a process that requires expertise across many disciplines.^1,2

Watch The Sandoz Approach to Biosimilars

Analytical characterization

• Multiple batches of reference biologic are procured over time¹
• Reference biologic is analyzed and characterized with highly sophisticated and innovative analytical tools that use a variety of analytical techniques to measure multiple parameters in multiple ways^1,3
• These data are then used to create the acceptable range of variability or “goalpost” for the biosimilar¹

Biologic proteins have inherent variability. It has been shown that biologic medicines demonstrate variations from batch to batch and over time, with no effect on safety, purity, or potency.^1,4,5

When developing biosimilar medicines, the variability of the reference molecule is measured through extensive analysis to determine the range or "goalposts" within which the biosimilar must fall.⁵

Biologic proteins have inherent variability. It has been shown that biologic medicines demonstrate variations from batch to batch and over time, with no effect on safety, purity, or potency.^1,4,5

When developing biosimilar medicines, the variability of the reference molecule is measured through extensive analysis to determine the range or "goalposts" within which the biosimilar must fall.⁵

Structural and function confirmation^1,5-7

• The biosimilar is formulated with a primary amino acid sequence that is 100% identical to that of the reference biologic
• All structural and functional elements of the biosimilar are compared with those of the reference biologic with powerful analytical tools to show the biosimilar is indistinguishable from its reference biologic

Watch how Sandoz engineers biosimilars to match the reference biologic 

Preclinical data⁵

• Includes an immunogenicity assessment
• Confirms tolerability and dosing

Clinical data

• Phase 1 pharmacodynamic (PD) and pharmacokinetic (PK) studies demonstrate that the biosimilar is indistinguishable from the reference biologic in terms of how the drug may behave in the body and how the body reacts to the drug^1,5,8
• Phase 3 confirmatory studies are performed in patient populations in sensitive indications¹
  • Compare the biosimilar with the reference biologic to confirm safety, efficacy, and immunogenicity²
  • Demonstrate that there are no other clinically meaningful differences between the medications⁵

The challenge for manufacturers to meet the FDA standard is to demonstrate their biosimilar is functionally and structurally as close as possible to the reference biologic, within its inherent variability.^1,2,5,9

• Biologics and their manufacturing processes possess an inherent degree of variability, even between different batches of the same medication⁹
• Because of unavoidable differences in the manufacturing processes, a biosimilar will not be entirely identical to the reference molecule⁹
• In order for the FDA to approve a biosimilar, a totality of evidence must be sufficient to demonstrate biosimilarity to the reference biologic⁵

Watch Biosimilar Trials Explained

The description of clinical trials in this educational video is not comprehensive of all clinical trial programs. This video is also not intended to serve as a patient recruiting tool for any clinical trial.  Patients and their healthcare professionals should consider entry into any clinical trial based upon a full understanding of the risks and any potential benefits of such trial. S-XBP-1336007