Alvotech Petitions FDA To Deny Interchangeability For Rival Stelara Biosimilars
Urges Agency Not To Approve Samsung Bioepis And Sandoz’s Pyzchiva As Interchangeable
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.
