Sandoz Development Process

SANDOZ DEVELOPMENT PROCESS

Our process has led to approvals in the US and worldwide1

The Sandoz process demonstrates biosimilarity

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 is highly similar to its reference product. Testing must ensure high similarity in safety, purity, and potency, with no clinically meaningful differences from the reference product, a process that requires expertise across many disciplines.1,2

Watch Biosimilar Trials Explained

Watch The Sandoz Approach to Biosimilars

Analytical Characterization

Analytical characterization

  • Multiple batches of reference product are procured over time1
  • Highly sophisticated and innovative analytical tools allow full characterization of the reference product3
  • A detailed analysis of the reference product is performed, using a variety of analytical techniques that measure multiple parameters in multiple ways1
  • These data are then used to create the boundaries, or "goalposts," of acceptable features for our biosimilar1
goal posts image

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.1,5,6

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

goal posts image

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.1,5,6

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

Indication

Structural and function confirmation1

  • The biosimilar is formulated with a primary amino acid sequence that is 100% identical to that of the reference product6
  • Comprehensive analysis of molecular structure and purity
    • Demonstration of higher-order structure at the protein level6
  • Biological functional assessment
    • In vivo assay and/or in vitro functional assays demonstrate biological characterization6
  • All structural and functional elements of the biosimilar are compared with those of the reference product with powerful analytical tools to show the biosimilar is indistinguishable from its reference product1,3
Preclinical data

Preclinical data

  • Contributes to the demonstration of biosimilarity and immunogenicity assessment6
  • Confirmation of tolerability and dosing6
Clinical data

Clinical data

  • Pharmacodynamic (PD) and pharmacokinetic (PK) studies in an appropriately-defined patient population.6 These confirm that the biosimilar is indistinguishable from the reference biologic in terms of how the drug may behave in the body1,2,6
  • Phase III studies are performed in patient populations in sensitive indications. These compare the biosimilar with the reference product to confirm safety, efficacy, and immunogenicity, and to demonstrate that there are no other clinically meaningful differences between the products2,7,8

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 product, within its inherent variability.1,2,6,8

  • Biologics and their manufacturing processes possess an inherent degree of variability, even between different batches of the same product8
  • Because of unavoidable differences in the manufacturing processes, a biosimilar will not be entirely identical to the reference product8
  • In order for the FDA to approve a biosimilar, a totality of evidence must be sufficient to demonstrate biosimilarity to the reference product6
Watch Biosimilar Trials Explained

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

References: 1. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91:405-417. 2. US Food and Drug Administration. Christl L. Overview of the regulatory pathway and FDA’s guidance for the development and approval of biosimilar products in the US. 3. Tsuruta LR, Lopes dos Santos M, Moro AM. Biosimilars advancements: moving on to the future. Biotechnol Prog. 2015;31(5):1139-1149. 4. Data on file. S-XBP-1335749. Sandoz Inc. Princeton, NJ. 5. Schiestl M. A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products. Biologicals. 2011;(39):297-299. 6. US Department of Health and Human Services. Scientific considerations in demonstrating biosimilarity to a reference product. Washington, DC: US Dept of Health and Human Services; April 2015. 7. NIH.gov. Clinical trial phases. https://www.nlm.nih.gov/services/ctphases.html. Published April 18, 2008. Accessed September 7, 2016. 8. Weise M, Bielsky M-C, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111-5117.