BIO Submits Comments on Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II
July 27, 2017
BIO submitted comments to the Food and Drug Administration (FDA) on the statement of work for assessment of the Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II.
BIO supports the approach described in the BsUFA II Performance Goals of establishing a review approach for biosimilars applications patterned generally after the program established under PDUFA V for New Molecular Entity (NME) and new Biological License Applications (BLAs).
BIO agrees the evaluation must be public, include input from FDA staff and sponsors, and provide recommendations at the mid-point and at the end of the program for any changes necessary for the program to succeed.
Download Full Comments Below
BIO Letter Communication 351(k) BLA In BsUFA- FINAL
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BIO submitted comments to the Food and Drug Administration (FDA) on the statement of work for assessment of the Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II.
BIO supports the approach described in the BsUFA II Performance Goals of establishing a review approach for biosimilars applications patterned generally after the program established under PDUFA V for New Molecular Entity (NME) and new Biological License Applications (BLAs).
BIO agrees the evaluation must be public, include input from FDA staff and sponsors, and provide recommendations at the mid-point and at the end of the program for any changes necessary for the program to succeed.