On 21 June 2018, the FDA withdrew the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity," issued in September 2017, after receiving public comments and the only citizen petition (FDA-2018-P-1876) filed by Sarfaraz K. Niazi, Adj. Professor, the University of Illinois and the founder of Pharmaceutical Scientist, on 14 May 2018, in his individual capacity.
The FDA Commissioner Scott Gottlieb, MD, ordering the withdrawal of the guidance expressed disappointment with the current pace of biosimilar development.
"As the cost to develop a single biosimilar product can reach hundreds of millions of dollars, it's important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain," Gottlieb said.
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The Niazi petition suggests waiving the bridging studies for qualified non-US comparators and encouraging payers to reimburse only for biosimilars when prescribed for new patients; the FDA Commissioner agrees. Further, Niazi pointed out several errors in the analytical similarity testing protocols and offered alternative approaches that limit the testing to non-release quality attributes to reduce the number of reference product batches required, a major issue; creating a mechanism to make reference samples available freely, allowing more ethical in vitro immunogenicity testing, where justified; minimizing non-inferiority testing in patients because of their lack of utility; allowing the use of surrogates and markers to prove clinical efficacy; and changing the pharmacokinetic testing to disposition-related parameters and allowing testing in more homogenous populations.
In a communication to Niazi on 26 June 2018, Dr. Janet Woodcock, the Head of the CDER at the FDA, acknowledged taking into considerations the recommendations made by Niazi to promote a more competitive and efficient pathway for the development of biosimilars.
"This quick action by the FDA is a historic step providing a remarkable opportunity to develop biosimilar at reduced time and cost by invoking creative, clinically relevant, approaches," said Niazi.