He continued: “The CTA approval for SCB-808 was supported by preclinical data comparing SCB-808 to both originator drug Enbrel® and other Chinese etanercept biosimilars. We believe that our superior biomanufacturing process, biosimilarity to Enbrel® and prefilled syringe formulation will allow us to have significant commercial advantages once SCB-808 is brought to the market.”
Currently available etanercept biosimilars in China were all developed and approved prior to the implementation of the CFDA’s Technical Guideline for Development and Evaluation of Biosimilars and were not compared to the originator drug Enbrel® in clinical trials to demonstrate their bioequivalence. Furthermore, they are only approved in the lyophilized powder formulation, which must be reconstituted typically by trained medical personnel before being subcutaneously injected into patients. SCB-808 is being developed in the prefilled syringe formulation, which is ready-for-injection and can potentially be self-administered by patients in the convenience of their own homes. Thus, in the Western world, ready-for-injection formulations constitute the overwhelming majority of Enbrel® prescriptions. As such, Clover’s SCB-808 has the potential to address the unmet needs of Chinese patients for this class of drugs.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases. Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. Additionally, Clover is leveraging its in-house cGMP biomanufacturing capabilities to develop select biosimilars. For more information, please visit our website: www.cloverbiopharma.com.