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Taking Biosimilars Down A PEG: Why Copying Neulasta Isn’t So Easy

Executive Summary

Biosimilar sponsors are 0-3 so far in attempts to win US FDA approval for copies of Amgen’s pegfilgrastim (Neulasta). FDA’s recent review of a novel clotting factor formulation offers a clue why it is turning out to be harder than it seems to copy a pegylated protein.

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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.

US FDA's Biosimilars Program: Five Years In, Complete Response Letters Still Outnumber Approvals

Agency is meeting its review timelines for biosimilar applications but handing our more complete response letters than first-cycle approvals; sponsors have publicly disclosed 24 original biosimilar application submissions to the agency since the review program began in fiscal year 2013, with 10 product approvals to date and at least 13 CRLs, according to the Pink Sheet's biosimilars report card.

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