Clover Biopharmaceuticals 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 Enbrel (etanercept). The drug is being developed in the prefilled syringe formulation for the treatment of rheumatoid arthritis and other autoimmune diseases. 

“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, Enbrel 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.”

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. Because of this, 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.