Biosimilars Pathway Dilemma: When Should Sponsors Pick (k) Before (a)?
Extrapolation and interchangeability appear to be the linchpins for biosimilar sponsors mulling whether to send applications to the emerging 351(k) pathway or the traditional novel biologics approval system.
You may also be interested in...
Absent guidance, the company says it is submitting proposals for trial designs it believes could demonstrate biosimilar interchangeability.
An abbreviated pathway for follow-on biologics was one of the biggest issues for biotech investors in the legislative debate over health care reform. Two years after enactment, FDA is still waiting for the first application.
Some early meeting requests from potential biosimilar sponsors were not held because they did not include the necessary information for FDA to give development advice.