On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz adalimumab biosimilar is currently under EMA review. As we reported here, the Sandoz rituximab biosimilar has been approved by the European Commission and as we reported here, the FDA has accepted Sandoz’s rituximab aBLA for review.
Two of the clinical trials involved switching between the Sandoz biosimilar and the reference drug. Sandoz reported that a Phase III study confirmed no clinically meaningful differences in efficacy, safety and immunogenicity between patients with moderate-to-severe chronic plaque psoriasis who continually received Humira®, those who continuously received the Sandoz adalimumab biosimilar and those who switched between Humira® and the Sandoz adalimumab biosimilar. Sandoz reported that another Phase III study demonstrated that for patients with rheumatoid arthritis who have been treated with rituximab in the past, the Sandoz rituximab biosimilar matched Rituxan® in safety and immunogenicity between patients who continuously received Rituxan® and those who switched from Rituxan® to the Sandoz rituximab biosimilar.
The other two clinical trials evaluated the bioequivalence of the Sandoz biosimilars and their reference drugs. According to Sandoz, a Phase 1 study demonstrated that the Sandoz adalimumab biosimilar matched Humira® in terms of safety, tolerability and immunogenicity and a confirmatory study demonstrated that the Sandoz rituximab biosimilar matched Rituxan® in efficacy, safety and immunogenicity.
Stay tuned to Big Molecule Watch for more updates.
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