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
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
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
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
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.