Biosimilar Approval: Better, Stronger, Faster

May 21, 2018By Sara W. Koblitz

We have the technology. It will definitely cost more than six million dollars, and there are questions about whether it will be better than it was before.  But Dr. Sarfaraz Niazi thinks he can rebuild the biosimilar approval process to make it more efficient.

In an interesting Citizen Petition posted last week on, Dr. Niazi provides recommendations to FDA to revamp and expedite the biosimilar approval process. Dr. Niazi, the Forbes-proclaimed “most interesting man revolutionizing the health world” and the man who coined the term “biosimilars,” a professor at the University of Illinois at Chicago and author of multiple bioequivalence textbooks.  In his May 11, 2018 Citizen Petition, he provides a myriad of suggestions for FDA to expedite the biosimilar approval process.

A freestanding petition (i.e. not submitted as a comment on an FDA proposal or a response to a request for information) that was apparently motivated by Commissioner Gottlieb’s speech at the American Health “Insurance Plans’ National Health Policy Conference in March 2018, the Petition addresses a wide range of biosimilar approval issues. Specifically, Dr. Niazi makes five suggestions:

  • Allow developers to use of a non-U.S.-licensed comparator product as the reference product without bridging studies;
  • Permit substitutions of a biosimilar for an originator product (without an interchangeable designation) for a naive or new patient;
  • Agree to the use of in vitro testing to reduce the need for clinical immunogenicity testing;
  • Waive certain PK/PD studies of biosimilars; and
  • Modify Critical Quality Attribute Tier 1 testing in analytical similarity.

Many of these ideas are not new and reflect some of the comments FDA received on its Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product. While FDA did not previously make changes in response to these comments, a new administration means new priorities.  Judging from the rapid pace of biosimilar approvals over the last year, this administration is actively trying to increase the number of biosimilars on the market.  Perhaps, given the timing and the increased push for biosimilar approval, FDA may use some of these ideas to hasten the biosimilar approval.