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

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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


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