Pfizer Inc. announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan (rituximab-U.S.)/MabThera1.
The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma.
“We are pleased to report on our fifth proposed biosimilar monoclonal antibody (mAb) with positive study results,” said Amrit Ray, M.D., global president, Pfizer Essential Health Research and Development. “These results reinforce the potential of our proposed rituximab biosimilar in providing a safe and effective treatment option for patients.”
Pfizer’s biosimilars pipeline consists of seven distinct biosimilar molecules in mid to late stage development, with three of them in oncology, as well as several others in early stage development.
1 Rituximab is marketed in the U.S. under the brand name Rituxan and marketed in the E.U. and other regions under the brand name MabThera. Rituxan and MabThera are registered trademarks of Genentech, Inc.
(Source: Pfizer Inc.)
Filed Under: Drug Discovery