Biosimilar Guidances Expected In ‘Near Future,’ But Unnecessary, FDA Says
This article was originally published in The Pink Sheet Daily
Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.
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FDA clinical reviewers moved from traditional “new drug” review mode to determining the evidence needed to demonstrate a follow-on product is highly similar to the reference biologic, Sandoz exec says, describing firm’s interactions with FDA on its filgrastim 351(k) application.
Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings
Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.