Alvotech has petitioned the US Food and Drug Administration to prevent certain Stelara (ustekinumab) biosimilar developers from gaining an interchangeability designation, based primarily on sialyation differences between products developed using different types of cell lines.
Alvotech Petitions US FDA To Deny Interchangeability For Rival Stelara Biosimilars
In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.
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