Next Steps For Interchangeable Biosimilars: Lifecycle Regulation Policy Development
Executive Summary
US FDA seeks stakeholder views on manufacturing changes, new reference product indications and other questions that build on its draft guidance for approval of interchangeable biosimilars.
You may also be interested in...
Biosimilar Post-Approval Change Guidance Coming From US FDA
Guidance, which is undergoing clearance, will address other products as well and might be released by the end of the year.
Biosimilar Post-Approval Change Guidance Coming From US FDA
Guidance, which is undergoing clearance, will address other products as well and might be released by the end of the year.
Interchangeable Biosimilar Designations Shouldn't Be Forever, Innovators Say
US FDA may need to withdraw previous interchangeability determination due to new indications or manufacturing changes, reference product companies say; generic firms say prior interchangeability designation should apply to new indications absent significant scientific questions.