With extensive experience, leading instrument and professional research team, CD BioSciences provides customers with clinical research service to facility the biosimilar development. We are dedicated to advancing and accelerating your biosimilar approval processes.
Biosimilar is a biological product which is highly similar to another already approved biological medicine (reference product), and there is not any clinically meaningful difference between the biological product and the reference product in terms of the safety, purity, immunogenicity and efficacy of the product. Biosimilar includes soluble receptors, hormones, growth factors and monoclonal antibodies, etc. It is a complex issue to demonstrate that one biosimilar is interchangeable with the reference product.
Fig.1 Overview of Food and Drug Administration (FDA) approach to biosimilar. (Wish, Jay B, 2014)
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The aim of clinical studies is to provide evidence about the comparability of efficacy and safety between a biosimilar and its reference agent. The phase 1 and phase 3 trials are included in the clinical research, while phase 2 trials are not required since the reference product's dosing has been established already.
Focusing on solving customers' most important and complex drug development problems, CD BioSciences is specialized in delivering comprehensive clinical trials service to efficiently navigate the development process of biosimilar drug. Please contact us to discuss what we can do in your biosimilar development process.
1. Christl, Leah. "FDA's overview of the regulatory guidance for the development and approval of biosimilar products in the US." US Food and Drug Administration (2016).
2. Isaacs, John, et al. "The biosimilar approval process: how different is it?." Considerations in Medicine 1.1 (2017): 3-6.
3. Wish, Jay B. "The approval process for biosimilar erythropoiesis-stimulating agents." Clinical Journal of the American Society of Nephrology 9.9 (2014): 1645-1651.
4. Azevedo, Valderilio, et al. "Biosimilars: considerations for clinical practice." Considerations in Medicine 1.1 (2017): 13-18.