FDA Meetings With Biosimilar Sponsors Aim To Make 351(k) Pathway OK
This article was originally published in The Pink Sheet Daily
Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.
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As FDA prepares for another public hearing on the pathway, FTC says the rules requiring biosimilar applicants to share information with their reference product competitors could lead to anti-competitive issues and may be an ongoing concern.
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