, Volume 33, Issue 1, pp 121–123 | Cite as

Comment on “The End of Phase 3 Clinical Trials in Biosimilars Development?”

  • Sarfaraz K. NiaziEmail author
Letter to the Editor

Dear Editor,

I agree with the prediction of Dr Frapaise in his manuscript The End of Phase 3 Clinical Trials in Biosimilars Development? [1] that a robust chemistry, manufacturing, and controls (CMC) package will obviate the need for powered clinical efficacy studies; I also applaud the comments made by Christopher J. Webster and Gillian R. Woollett on Dr Frapaise’s article [2]. I wish to provide additional clarification to make Dr Frapaise’s argument and the Webster and Woolett suggestions more relevant, based on my recent publications [3, 4, 5] and filing a Citizen Petition [6] against the FDA to change the regulatory guidance. My pivotal suggestion to the FDA was to waive clinical efficacy studies on the ground of their irrelevance, as suggested by Dr Frapaise. My Citizen Petition, along with comments made by other developers, resulted in the FDA withdrawing its pivotal guidance [7], and issuing a Biosimilars Action Plan (BAP) [8, 9] to carve out new regulatory guidance for...


Compliance with Ethical Standards


No funding was received.

Conflict of interest

Sarfaraz K. Niazi has no conflicts of interest.


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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.University of IllinoisChicagoUSA

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