FDA, WHO Biosimilar Naming Proposals Take Shape

FDA appears to be awaiting HHS clearance of its guidance, while WHO has released its proposal for public comment.

After a long wait, it appears FDA and the World Health Organization have both made decisions about biosimilar naming conventions.

FDA’s policy has yet to be released and the WHO policy is a draft, but they at least will provide some direction for sponsors, including those looking to use the...

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