Pfizer Says Potential Biosimilar to Rituximab Shows Comparable Safety and Efficacy

Pfizer (PFE) said Monday a comparative safety and efficacy study of PF-05280586 versus Rituxan/MabThera met its primary endpoint of overall response rate at week 26 of a 52-week study.

PFE shares rose more than 1% in pre-market trading.

Rituxan/MabThera is indicated for the treatment of patients with certain types of CD20-positive non-Hodgkin lymphoma, CD20-positive chronic lymphocytic leukemia, rheumatoid arthritis and other conditions.

Data from the ongoing 52-week Reflections study demonstrated no clinically meaningful differences in efficacy, in terms of overall response rate at week 26, between PF-05280586 and MabThera, for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma, or LTB-FL. MabThera is produced by drugmaker Roche.

Pfizer believes that, if approved, PF-05280586 may help provide a more cost-effective treatment option and expand access for patients and physicians.

PF-05280586 has been accepted for review by the FDA, and a goal date for a decision by the FDA is in Q2 2019. Pfizer is also working towards making PF-05280586 available for patients in Europe. Further results on the safety and efficacy from the 52-week study in LTB-FL are expected to be presented next year.

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