- SCB-808, a Prefilled Syringe Formulation Etanercept Biosimilar Candidate, Received CTA Approval from the CFDA
CHENGDU, CHINA, December 22, 2017 — Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, today announced it has received Clinical Trial Application (CTA) approval from the Chinese Food and Drug Administration (CFDA) to conduct clinical trials in China with SCB-808, a proposed biosimilar of Enbrelâ (etanercept) being developed in the prefilled syringe formulation for the treatment of rheumatoid arthritis and other autoimmune diseases. A phase I clinical trial is planned to initiate in China in mid-2018.
“We are delighted to receive this clearance, as it further validates Clover’s in-house cGMP biomanufacturing expertise and research capabilities,” said Dr. Peng Liang, co-founder, Chairman and President of Clover. “Generating over US$ 9 billion in global product sales in 2016, Enbrelâ is a transformative therapy for rheumatoid arthritis and other autoimmune disease patients. Thus, we look forward to initiating the SCB-808 clinical development program, with the ultimate goal of making SCB-808 widely available to Chinese patients at an affordable price.”
He continued: “The CTA approval for SCB-808 was supported by preclinical data comparing SCB-808 to both originator drug Enbrelâ and other Chinese etanercept biosimilars. We believe that our superior biomanufacturing process, biosimilarity to Enbrelâ 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 Enbrelâ 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 Enbrelâ 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.