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Sorrento announces its biosimilar to infliximab meets primary endpoints in phase 3 trial

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Sorrento Therapeutics Inc. recently announced in a press release that its infliximab biosimilar, ST-002, met its primary endpoints in a phase 3 study of patients with rheumatoid arthritis.

The study included 330 patients with rheumatoid arthritis (RA) in China who received the infliximab (Remicade, Janssen) biosimilar ST-002 in addition to methotrexate. According to the release, similar clinical efficacy in ACR20, ACR50 and ACR70 responders (77%, 50% and 20% of patients with RA, respectively) was observed, and the immunogenicity and formation of anti-drug antibodies were “drastically reduced” compared with published studies of the Remicade originator product (up to 5% vs. about 40% of patients).

According to the release, the company’s partner MabTech Ltd. completed the phase 3 trial in China and is applying for marketing approval of STI-002 in that country. Sorrento Biologics, a wholly owned subsidiary of Sorrento, will develop and commercialize ST-002 in North America, Europe and Japan.

Reference:

www.sorrentotherapeutics.com