Biosimilars for treating follicular lymphoma – update on clinical trials

Wojciech Jurczak, MD, from the Jagiellonian University, Krakow, Poland, discusses clinical trials using biosimilars to treat follicular lymphoma at the American Society of Hematology (ASH) Congress 2016 in San Diego, CA. He argues that rituximab was one of the first immuno-therapy drugs, which was a great improvement some years ago, and highlights that rituximab biosimilars are likely to be available in Europe from early 2017. Dr Jurczak discusses two clinical trials of rituximab biosimilars which were presented at ASH 2016. In the first, the ASSIST_FL trial (NCT01419665), over 600 patients with follicular lymphoma (FL) were treated, and the primary target of response rate (RR) was found to be identical when comparing the biosimilar GP2013 with original rituximab, with no safety concerns. This trial is still ongoing but results on progression-free survival (PFS) should be available soon, and data have been submitted to the European Medicines Agency (EMA). In the second trial, which was presented in a poster which Dr Jurczak co-authored with Bertrand Coiffier, who presented the original rituximab drug 15 years ago, the pharmacokinetics and other factors important for a registration trial of the biosimilar xxx were assessed in 120 patients with follicular lymphoma (NCT02162771). However, according to Dr Jurczak, this drug will still need some time for development until it is registered.

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