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Pfizer’s rituximab biosimilar succeeds in phase III follicular lymphoma trial

Pfizer’s PF-05280586, a potential biosimilar to rituximab, has met its primary endpoint of overall response rate in a clinical trial of patients with CD20-positive follicular lymphoma and low tumor burden.

The randomized, double-blind REFLECTIONS B3281006 clinical trial assessed the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 in comparison to rituximab.

It demonstrated equivalence of the biosimilar candidate in overall response rate (ORR) in the first-line setting. ORR was defined as the primary endpoint of the trial, measured according to the revised response criteria for malignant lymphoma at week 26.

Rituximab, which is branded as MabThera outside the US, is indicated for the treatment of patients with certain types of CD20-positive non-Hodgkin’s lymphoma, granulomatosis with Polyangiitis, Microscopic Polyangiitis, CD20-positive chronic lymphocytic leukemia, rheumatoid arthritis, and other region-specific indications.

Pfizer Essential Health Research and Development global president Amrit Ray said: “We are pleased to report on our fifth proposed biosimilar monoclonal antibody (mAb) with positive study results. These results reinforce the potential of our proposed rituximab biosimilar in providing a safe and effective treatment option for patients.

“As a global leader in novel biologics, and with one of the broadest global portfolios in oncology, we are delivering on our commitment to advancing high-quality medicines for the millions of patients with cancer around the world today and in the future.”

Pfizer’s biosimilars pipeline is made up of seven distinct biosimilar molecules, currently in mid to late stage development. Three of the candidates are related to oncology.

Last month, Pfizer’s IXIFI (PF-06438179, infliximab-qbtx), a biosimilar of Remicade (infliximab), which is a rheumatoid arthritis drug from Johnson & Johnson’s, was approved by the US Food and Drug Administration (FDA) for all indications of the reference product.


Image: Pfizer world Headquarters in Manhattan, New York. Photo: courtesy of Coolcaesar/Wikipedia.org.