New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product
ASSIST-FL trial demonstrates equivalent safety, efficacy, pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar rituximab (GP2013) to the reference product. Interim data in over 600 adults show potential of GP2013 as an alternative rituximab Sandoz proposed biosimilar rituximab is the company's first monoclonal antibody candidate Holzkirchen, December 5, 2016 - Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced data from the ASSIST-FL trial. The confirmatory safety and efficacy study shows GP2013 met its primary endpoint of overall response rate (ORR), demonstrating equivalence with the reference product, MabThera *, in 629 patients. Results were presented at the 58th Annual Meeting of the American Society of Hematology (ASH). The combination treatment phase of the ASSIST-FL study - the first of a three-phase protocol - confirms that, for patients with previously untreated advanced follicular lymphoma, the ORR of GP2013 (87.1%) and the reference product (87.5%) were equivalent. Consistent with clinical practice, patients received cyclophosphamide, vincristine and prednisone (CVP) in addition to reference product or GP2013. The final results of the ASSIST-FL study are expected in 2018 after study completion.
