FDA “Busy” With Biosimilars; Sponsors Already In Pre-IND Meetings
Several sponsors appear to be taking advantage of the FDA’s biosimilar pathway, even though the agency has yet to clarify how it will handle the applications.
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FDA says some candidates have appeared so different from their reference products that sponsors were told the molecule could not be a biosimilar.
Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.
The biosimilar manufacturing and development process has been optimized to ensure multiple companies can enter the market, Sanford C. Bernstein & Co. Senior Health Care Analyst Ronny Gal argues, but uncertainty will remain until FDA designs its approval system.