Biosimilar

Biosimilar

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

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)

Explore Our Customized Clinical Service for Your Biosimilar Product

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.

• According to the latest regulation and guidance of U.S. Food and Drug Administration (FDA) about biosimilar, we design a customized clinical protocol and full clinical development plan to ensure your product satisfy global regulatory requirements.
• A powerful biosimilar investigation platform simplifies the site recruitment and research start-up process.
• With the extensive experience and in-depth understanding of patient identification, recruitment, and retaining in clinical trials. We can minimise the risks inherent in patient recruitment.
• We provide adequate clinical pharmacokinetic (PK) and pharmacodynamic (PD) data, biomarker studies and sufficiently large randomised comparative trials for the demonstration of clinical equivalence.
• Considering the subtle changes in the protein structure or delivery of a biosimilar may lead to the increasing of immunogenicity, we provide comprehensive immunogenicity studies for your biosimilar product.
• To ensure the patient protection and reliable trial results, we promise fast delivery of high quality data.

Our Highlights

• The experienced expert teams provide comprehensive comparative studies on safety, immunogenicity and potency between biosimilar and reference product.
• We use leading technologies, instruments and analytical methods to ensure that deliver accurate experimental data to clients on time.

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.

References:

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.