Posted: 20 May 2018 08:03 PM PDT
In an interesting Citizen Petition posted last week on regulations.gov, 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.
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