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