Sorrento Announces Successful Phase III Trials for Biosimilars of Erbitux (cetuximab) and Remicade (infliximab)

Biosimilar News

On January 11th, Sorrento Therapeutics announced that its partner, MabTech Ltd., had successfully completed Phase III clinical trials in China for two drugs: STI-001, a biosimilar of Eli Lilly’s Erbitux (cetuximab), and STI-002, a biosimilar of Janssen Biotech’s Remicade (infliximab). Both STI-001 and STI-002 met their primary endpoints in confirmatory, randomized, controlled, two-part Phase 3 studies. Furthermore, according to Sorrento, STI-001 showed significantly less adverse events than Erbitux, and immunogenicity and anti-drug antibody formation were drastically reduced for STI-002 compared to Remicade.

Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of metastatic colorectal cancer, metastatic non-small cell lung cancer, and head and neck cancer. Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α) used to treat autoimmune diseases such as rheumatoid arthritis.

MabTech is applying for marketing approval of the two biosimilar candidates in China, while Sorrento Biologics, a wholly owned subsidiary of Sorrento Therapeutics, will develop and commercialize the biosimilar candidates in North America, Europe, and Japan.

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