Lupin’s Pegfilgrastim Biosimilar 351(k) Application Being Evaluated by FDA

Mumbai, India-based Lupin Ltd is attempting to enter the US biosimilar market for the first time with its version of pegfilgrastim. First approved and marketed in India in 2015, Lupin’s pegfilgrastim application was accepted on June 2 by the Food and Drug Administration.

The development of this agent included three double-blind, controlled trials, comprising more than 3,000 patients, in addition to the analytical, pharmacokinetic, and immunogenicity studies expected to support a 351(k) biosimilar application.

Based on the filing date, an FDA decision may be expected in Q2 2022. If approval is received, Lupin will be entering a crowded market as the fifth biosimilar pegfilgrastim. Currently, the pegfilgrastim category is dominated by the on-body injector Neulasta® product OnPro as well as the biosimilar brands Udenyca®, Fulphila®, Nyvepria®, and Ziextenzo®.

Lupin is not a stranger to the biosimilar area. Besides pegfilgrastim, the company launched its version of etanercept in the European Union as well as Japan and India, and it has a phase 3 study underway for a biosimilar of ranibizumab. To date, Lupin has not announced any marketing agreements with other manufacturers on the biosimilar front. The company has a strong US presence (based in Baltimore) for its generic business.

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