Our process has led to approvals in the US and worldwide1
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 ways1,3
- 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 confirmation1,5-7
- 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 drug1,5,8
- 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
References: 1. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91:405-417. 2. Przepiorka D, Deisseroth A, Lee K, Nie L. Clinical Trial Review presented at: FDA Oncologic Drugs Advisory Committee Meeting; January 7, 2015; Silver Spring, MD. https://wayback.archive-it.org/7993/20170405222944/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM431118.pdf. Accessed October 30, 2018. 3. Tsuruta LR, Lopes dos Santos M, Moro AM. Biosimilars advancements: moving on to the future. Biotechnol Prog. 2015;31(5):1139-1149. 4. Schiestl M. A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products. Biologicals. 2011;(39):297-299. 5. 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. 6. Visser J, Feuerstein I, Stagnier T, et al. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. BioDrugs. 2013;27(5):495–507. 7. da Silva A, Kronthaler U, Koppenburg V, et al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma. 2014;55(7):1609-1617. 8. US Food and Drug Administration. FDA Presentations for the January 7, 2015 meeting of the Oncologic Drugs Advisory Committee Meeting: ZARXIO® (filgrastim). January 7, 2015. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM431118.pdf. Accessed September 19, 2017. 9. Weise M, Bielsky M-C, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111-5117.