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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