Biosimilars Update: Bio-Thera Solutions BAT1706 (bevacizumab) and Pfizer RUXIENCE (rituximab)

Below are a few biosimilar-related updates from the past week.

Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.”  Bio-Thera indicated that “[r]esults of the study will be presented in full at a future medical meeting or summarized in [a] publication.”

Pfizer announced that its RUXIENCE (rituximab) received a positive opinion from the European Medical Agency Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorization for Pfizer’s biosimilar.  Pfizer’s regulatory submission was supported by a data package demonstrating the biosimilarity of RUXIENCE to the reference product, MABTHERA.  The CHMP’s opinion will be reviewed by the European Commission, with a regulatory decision anticipated in the first half of 2020.  Pfizer stated that “[i]f approved, RUXIENCE would become Pfizer’s fifth oncology biosimilar to receive regulatory approval.”  RUXIENCE was approved in 2019 for use in the United States for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis and, according to Pfizer, “was recently made available to U.S. patients.”