Clover Initiates Phase 1 Trial of Proposed Etanercept Biosimilar

China-based Clover Biopharmaceuticals recently announced that the first patient was dosed in a phase 1 trial of SCB-808, a potential etanercept (Enbrel) biosimilar.

SCB-808 is being developed in a prefilled syringe presentation for the treatment of rheumatoid arthritis and other inflammatory diseases. The trial is investigating the pharmacokinetics, safety, and immunogenicity of subcutaneously administered SCB-808 compared with the reference product.

“This milestone marks Clover’s second biologic product to initiate human clinical trials in as many months. Now with clinical trials actively enrolling patients in multiple countries, Clover has demonstrated its ability to execute on its goals across multiple functional areas,” said Joshua Liang, chief strategy officer and board director at Clover, in a statement.

Currently, in the Chinese market, the etanercept biosimilars that are available were not subject to clinical trials in direct comparison to the reference etanercept, Enbrel. The development and approval of the products occurred prior to the implementation of the China Food and Drug Administration’s (CFDAs) Technical Guideline for Development and Evaluation of Biosimilars document.

Given this fact, the approved etanercept biosimilars exist only in lyophilized powder formulations, which must be reconstituted before being administered to patients subcutaneously by a medical professional. Clover says that SCB-808 can potentially address the unmet needs of Chinese patients to self-administer with the prefilled syringe.

“Having compared SCB-808 to both Enbrel and other Chinese etanercept biosimilars in preclinical studies, we believe that our superior biomanufacturing process, biosimilarity to Enbrel, and convenient ready-for-injection prefilled syringe formulation will allow us to have significant commercial advantages once SCB-808 is brought to the market,” said Peng Liang, MD, co-founder, chairman, and president of Clover, in a statement.