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FDA declines proposed Rituxan biosimilar from Sandoz
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The FDA has rejected approval of Sandoz’s biologics license application for GP2013, a proposed rituximab biosimilar, issuing a Complete Response Letter for the product.
“While disappointed, Sandoz remains committed to further discussions with the FDA in order to bring this important medicine to U.S. patients as soon as possible,” Sandoz said in a statement. “There is a substantial unmet need for access to safe and effective therapies. Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilar medicines.”
In June 2017, the Sandoz biosimilar — under the trade name Rixathon — received approval from the European Commission for all indications of its rituximab (Rituxan; Genentech, Biogen) reference product, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
The European Commission based its approval on analytical, preclinical and clinical data, including the phase 3 ASSIST-FL study, which confirmed equivalent efficacy and comparable safety between GP2013 and rituximab after 6 months, and the ASSIST-RA study, which demonstrated equivalent safety, efficacy, pharmacokinetics and pharmacodynamics between GP2013 and rituximab.
Following the biosimilar’s European approval, Sandoz submitted its biological license application for GP2013 to the FDA through the 351(k) pathway in September 2017.
“Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter,” the company said in a statement. “As the pioneer and global leader in biosimilar medicines, Sandoz has five biosimilar medicines currently marketed in various countries worldwide, as well as a leading global pipeline.”