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Mylan's Fulphila Sets Up The US Market For The Next Biosimilar Showdown

Executive Summary

Mylan has priced its biosimilar version of pegfilgrastim at a 33% discount to Amgen's WAC for Neulasta, steeper than the 15% discount Pfizer initially offered for Inflectra. The commercial outcome for Fulphila could set the tone for future US biosimilars, which have yet to take off.

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Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies

Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies

Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

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