Pfizer’s Ruxience (biosimilar, rituximab) Receives CHMP’s Positive Opinion for Cancer and Autoimmune Diseases

Pfizer’s Ruxience (biosimilar, rituximab) Receives CHMP’s Positive Opinion for Cancer and Autoimmune Diseases

Shots:

  • The EMA’s CHMP has adopted a positive opinion, recommending MAA for Ruxience, a biosimilar referencing MabThera
  • The regulatory submission is based on REFLECTIONS B3281006 study assessing the efficacy, safety, immunogenicity, PK/PD of Ruxience demonstrating biosimilarity to the reference product in patients with CD20+, low tumor burden FL
  • Ruxience is a mAb indicated for the treatment of NHL, CLL, RA, GPA, MPA, PV and has received the US FDA’s approval in 2019 with its anticipated EC’s approval in H1’20. If approved, RUXIENCE will be Pfizer’s fifth oncology biosimilar to receive regulatory approval in EU

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: WSJ