Pfizer Lines Up European Pegfilgrastim
Receives CHMP Nod For Nyvepria Version Following US Approval
Pfizer has received an endorsement for a pan-European marketing authorization for its Nyvepria pegfilgrastim biosimilar from the EMA’s CHMP. However, the company would not be drawn on commercialization plans amid competition from numerous other approved versions.
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Pfizer has won the first US Food and Drug Administration biosimilar approval this year, for its Nyvepria (pegfilgrastim-apgf) pre-filled syringes. However, it must overcome intellectual property hurdles before it can roll out the product.
Pfizer has announced that it does not plan to market its Amsparity adalimumab biosimilar in Europe despite it having been endorsed by the EMA in December and being in line for an imminent approval from the European Commission.
A flurry of financial appointments has been seen across the off-patent industry, involving major players Dr Reddy’s, Biocon, Mayne Pharma and Xbrane Biopharma.