IP Barriers Block Pfizer Following US Pegfilgrastim Approval
Sixth Oncology Biosimilar Approval Chalked Up
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.
You may also be interested in...
Pfizer And Amgen Strike A Deal To Settle US Pegfilgrastim Tussle
Pfizer’s Nyvepria biosimilar was the fourth pegfilgrastim biosimilar approved by the FDA, despite ongoing litigation from originator Amgen. The biosimilar sponsor has cleared any niggling legal issues by settling litigation over a US patent directed at methods of protein purification.
Pfizer Eyes EU Pegfilgrastim Roll-Out By 1 April As US Launch Is Confirmed
Pfizer will aim to have its biosimilar Neulasta (pegfilgrastim) product, Nyvepria, on the market in both the EU and US by the end of the current quarter, a company spokesperson has informed Generics Bulletin, following a successful US launch.
Pfizer’s Pegfilgrastim Biosimilar ‘Has Launched’ In The US
Pfizer has pressed on with the launch of a fourth biosimilar pegfilgrastim product, Nyvepria (pegfilgrastim-apgf), according to an investment bank. With Amgen continuing to hold more than 70% of the market, there is opportunity for Pfizer to capture significant market share.