Keeping Track Of Approvals: Two Novel Drugs (Givlaari And Xcopri), A Project Orbis Collaboration (Calquence) And Another Humira Biosimilar
The latest news on US FDA drug approvals.
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US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.
Pfizer has secured FDA approval for its adalimumab biosimilar under the name Abrilada, representing the agency’s 25th biosimilar approval overall. However, patent settlements around the Humira brand mean that Pfizer is not due to enter the market for four years.
Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals
The latest news on US FDA user fee decisions and submissions to the agency.