Petition Urges FDA to Overhaul Biosimilar Approval Rules

A leading biosimilars scholar has filed an extensive citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval requirements, arguing that current regulations impose unnecessary clinical testing, inflate development costs, and delay access to lower-cost biologic products.

The petition, submitted by Sarfaraz K. Niazi, an adjunct professor of pharmaceutical sciences at the University of Illinois and a long-time critic of U.S. biosimilar policy, calls on FDA commissioner Marty Makary to take eight major administrative actions. These include setting public biologic product specifications through the U.S. Pharmacopeia, automatically granting interchangeability to all approved biosimilars, waiving many clinical immunogenicity and pharmacokinetic studies, ending the four-letter naming suffix rule, and allowing non-U.S. reference biologics to be used without bridging studies.

Niazi argues that the United States trails international regulators in modernizing biosimilar requirements and continues to mandate scientifically outdated testing that provides “no clinical or safety value.”

The petition asks FDA to:

• • Order the U.S. Pharmacopeia to create public standards — including analytical methods, reference materials, and release specifications — for each biologic. Niazi says this would replace the current system in which every biosimilar developer must independently buy and analyze multiple lots of the brand-name reference product.
• • Automatically deem all biosimilars interchangeable if they meet the statutory standard of showing no clinically meaningful differences, eliminating switching studies that he says “have no scientific justification” and are not required by any major global regulator.
• • Waive routine clinical immunogenicity trials, replacing them with validated filtration or size-exclusion chromatography steps to remove protein aggregates—defined as the primary drivers of immune reactions.
• • Waive pharmacokinetic studies for biologics where they do not provide meaningful information, including intraocular drugs with negligible systemic exposure and intravenous biologics that behave like generic IV drugs.
• • Eliminate FDA’s four-letter suffix for biologic names, which the petition says creates prescribing confusion and is inconsistent with global naming systems.
• • Permit non-U.S. reference biologics without bridging studies when the foreign product is identical in formulation and supported by equivalent clinical data.
• • Engage the U.S. Patent and Trademark Office and Congress to address what the petition characterizes as scientific issues with “double-patenting practices” that delay biosimilar competition.
• • Strengthen international harmonization, including mutual reliance and joint reviews, to reduce duplicative testing.

The petition argues that modern analytical technologies — such as advanced mass spectrometry and nuclear magnetic resonance — are vastly more sensitive than clinical trials in detecting meaningful structural differences between biologic products. Requiring developers to re-collect brand-name lots, conduct switching studies, or run pharmacokinetic trials based on small-molecule drug standards represents “scientifically unnecessary elements that hinder patient access,” Niazi writes.

He estimates the proposals — especially USP-based standards — could cut biosimilar development costs by $20 million per program and reduce timelines by at least 18 months.

The petition also cites FDA’s own recent actions, including waiving immunogenicity studies for insulin biosimilars and permitting foreign reference comparators in certain programs, as evidence that the agency is already moving toward a reduced clinical burden.

Niazi also warns that the U.S. patent system — particularly what he describes as inconsistent rulings on double-patenting — allows manufacturers to extend exclusivity beyond standard periods.