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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Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
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.