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IP Barriers Block Pfizer Following US Pegfilgrastim Approval

Sixth Oncology Biosimilar Approval Chalked Up

 
• By Dean Rudge

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.

PfizerSign
Pfizer's biosimilar portfolio now includes six FDA-approved oncology products • Source: Shutterstock

Pfizer’s Nyvepria (pegfilgrastim-apgf) 6mg pre-filled syringe formulation has been approved by the US Food and Drug Administration but will remain off the market for now, as the company continues to grapple with Amgen over intellectual property shielding its Neulasta (pegfilgrastim) reference product.

Amgen sued Pfizer in February this year, alleging infringement of US patent 8,273,707 directed at methods of protein purification

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