The role of biosimilars
What are biosimilars?
Biosimilars are biologic medicines that are highly similar to their reference biologic, as they have demonstrated no clinically meaningful differences in safety, purity, and potency compared to that of the reference biologic.1
Because biologics are larger, more complex, and of higher molecular weight than small-molecule medicines, biosimilars are subject to a step-wise, multifaceted regulatory approval pathway.1
Biosimilars are not generics2
In order to prove biosimilarity and gain FDA approval, biosimilar data must include analytical studies, pre-clinical testing, and clinical trials, which typically include a comparative design study or studies which are sufficient to demonstrate safety, purity, and potency.1
Biosimilarity based on a Totality of Evidence1
The FDA established an approval pathway for sponsors of a biologic product seeking approval as a biosimilar to a reference product based on a totality of evidence.
- To gain approval, a biosimilar must be comparable to the reference biologic in terms of structure, function, animal toxicity, human pharmacokinetics (PK) and pharmacodynamics (PD), immunogenicity, clinical safety, and efficacy1
Biosimilar development goal: Demonstrate biosimilarity to reference biologic1,8
*The nature and scope of the clinical study or studies will depend on the nature and extent of residual uncertainty about biosimilarity after conducting structural and functional characterization and, where relevant, animal studies.
Please visit Sandoz-biosimilars.com to learn more about Sandoz leadership in the newly emerging market of biosimilars
Sandoz: the biosimilar pathway pioneer
The efforts of Sandoz led to the development of the first biosimilar to receive FDA approval. Sandoz selected comprehensive methods to fully characterize and evaluate ZARXIO in order to meet all FDA requirements.9
*The use of EU-approved NEUPOGEN® as comparator for the non-clinical development of ZARXIO is considered justified by the high level of similarity between EU-approved and US-licensed NEUPOGEN®.14
References: 1. 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. 2. US Food and Drug Administration. Information for consumers (biosimilars). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped andApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm. Accessed May 3, 2017. 3. Revers L, Furczon E. An introduction to biologics and biosimilars. Part I: Biologics: what are they and where do they come from? Canadian Pharmacists Journal/Revue des Pharmaciens du Canada. 2010;143(3):134-139. 4. Declerck PJ. Biologicals and biosimilars: a review of the science and its implications. GaBI Journal. 2012;1(1):13-16. 5. US Food and Drug Administration. Frequently asked questions about therapeutic biological products. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped andApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm. Accessed May 3, 2017. 6. Cortés J, Curigliano G, Diéras V. Expert perspectives on biosimilar monoclonal antibodies in breast cancer. Breast Cancer Res Treat. 2014;144(2):233-239. 7. Brinks V. Immunogenicity of biosimilar monoclonal antibodies. GaBl Journal. 2013;2(4):188-193. 8. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91:405-417. 9. FDA approves first biosimilar product Zarxio [press release]. US Food and Drug Administration; March 6, 2015. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm436648.htm. Accessed May 3, 2017. 10. Data on file. Sandoz Inc. Princeton, NJ. 11. Blackwell K, Semiglazov V, Krasnozhon D, et al. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015;26(9):1948-1953. http://annonc.oxfordjournals.org/content/26/9/1948.full.pdf. Accessed May 3, 2017. 12. ZARXIO Prescribing Information. Sandoz Inc. August 2019. 13. NEUPOGEN® Prescribing Information. Amgen Inc. June 2018. 14. US Food and Drug Administration. Slides for the January 7, 2015 Meeting of the Oncologic Drugs Advisory Committee. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM431118.pdf. Published January 7, 2015. Accessed May 3, 2017.
ZARXIO is a registered trademark of Novartis AG.
NEUPOGEN is a registered trademark of Amgen Inc.