Stakeholders weigh in on BsUFA IV enhancements

Industry stakeholders are calling for enhancements to the US Food and Drug Administration’s (FDA) Biosimilar User Fee Amendments (BsUFA) program amid negotiations to reauthorize the program for another five years.

Specifically, they recommended giving more authority to Office of Therapeutic Biologics and Biosimilars (OTBB) reviewers, discontinuing the practice of requesting direct pharmacokinetic (PK) comparisons against US-sourced reference products, and aligning BsUFA with the Prescription Drug User Fee Act (PDUFA) by mandating that minor resubmission be reviewed in two months instead of the current six months.

These comments were submitted in response to a notice published in December where FDA sought feedback on which elements of BsUFA should be retained, modified, or eliminated. In the notice, FDA also announced a public meeting to gauge the industry's response to the overall performance of the current BsUFA program. (RELATED: BsUFA: Industry seeks enhancements for next biosimilars program, Regulatory Focus 3 December 2025)

The authority for BsUFA expires in September 2027. New legislation will be required for FDA to continue collecting user fees in future fiscal years.

The Biosimilars Forum captured the sentiments expressed by many comments. In its response, the group said that “despite the promise of biosimilars and FDA’s important work to date, barriers remain to their development and widespread adoption.”

Reviewers should have more control

Two industry groups suggested that under BsUFA, OTBB reviewers should have more authority to approve new biosimilars instead of that authority residing with reviewers in other offices specializing in a specific therapeutic area.

The Biologics Forum wrote that “after 15 years of biosimilar review by the FDA’s Office of Therapeutic Biologic Drugs and Biosimilars (OTBB), the FDA should enhance OTBB’s authority within the agency. Despite OTBB’s scientific and technical expertise, FDA’s current structure includes additional layers that slow the review and approval process. Under the existing organizational structure, clinicians who specialize in a particular therapeutic area and are in a separate FDA office render decisional actions for biosimilar applications. This makes little sense given the differing regulatory frameworks for biosimilars and originator biologic drugs.”

In its comments, the Biosimilars Council, a division of the Association for Accessible Medicines (AAM) reiterated the need for shifting review responsibility to OTBB.

“Given the increased reliance on analytical data in lieu of clinical efficacy studies, it makes little sense for clinical reviewers to retain signatory authority over biosimilar applications. Shifting this responsibility to the Office of Therapeutic Biologics and Biosimilars will both simplify and streamline biosimilar reviews and also create efficiencies for originator applicants, with clinical reviewers able to more appropriately focus their time on shepherding those innovative therapies to market—all of which increases competition and innovation to the benefit of U.S. patients.”

Celltrion recommends changing timeline for minor resubmissions

Celltrion, a biopharmaceutical company based in Incheon, South Korea, recommended that the timeline for reviewing resubmitted biosimilar applications should be aligned with the performance goals in PDUFA.

Under the current BsUFA performance goals, all resubmitted 351(k) biologics license applications (BLAs) carry a uniform 6-month review goal, regardless of whether the resubmission involves only minor issues, while under PDUFA, minor resubmissions are reviewed within two months while major resubmissions are reviewed within six months.

The company pointed out that “this is discrepancy between PDUFA and BsUFA policies unjustifiably prolongs BLA reviews, creating unnecessary delays in patient access to much needed biological drug products.”

Celltrion proposed a review timeline of two months for resubmissions related to complete response letters that address minor review issues, in accordance with the regulatory policy and procedures outlined in MAPP 6020.4, Rev. 3.

AAM suggests eliminating PK comparisons

AAM also said that the agency should “discontinue the Agency’s internal practice of routinely requesting direct PK comparisons against U.S.-source reference product.”

This request is consistent with a Citizen Petition submitted by the group to the FDA, which recommends that the agency eliminate the routine requirement for three-way pharmacokinetic (PK) studies. These studies typically compare US-sourced and non-US-sourced versions of the reference product, along with the proposed biosimilar arm, in cases where studies using a non-US-sourced reference are included in the submission.

AAM said that these studies “are generally unnecessary from a safety and effectiveness perspective, but they do impose substantial development costs (including the high costs associated with procuring reference product sourced from the U.S. that can contribute to the entrenchment of the biosimilar void.”

AAM cited a report by IQVIA, published in February 2025, which found that between 2025 and 2034, only 10% of the 118 originator biologics losing patent exclusivity over the next 10 years currently have a biosimilar in development.

The Biosimilars Forum similarly noted that “the American healthcare system faces a major void of development and availability of biosimilars in the near future due to the ongoing regulatory and marketplace barriers that have been in place for the last decade, which have hampered biosimilar development and free-market competition.”

Eliminate the biosimilar suffix, deems all biosimilar interchangeable

The Biosimilars Forum also suggested that FDA eliminate use of the biosimilar suffix which follows the nonproprietary name.

This step would “catalyze biosimilar development and uptake.” The group said that creating the suffix was not needed and has been superseded by the implementation of the Drug Supply Chain Security Act (DSCSA) enacted in 2013 which tracks medicines down to batch or lot number. “The USA is the only country in the world that adds suffixes to the non-proprietary name of biological drugs,” said the Forum.

The Forum recommended designating all biosimilars as interchangeable and not requiring switching studies. “Interchangeability is a legal distinction and not a clinical one. The statute is clear that the interchangeability designation is to enable dispensing by pharmacists (subject to state law) and not prescribing by physicians—who can prescribe any medicine for any purpose they consider clinically appropriate regardless of their interchangeability status. “

The group also suggested updating and maintaining accurate information in the Purple Book. The FDA’s Purple Book Database of Licensed Biological Products includes information on products that are approved as both biosimilar and interchangeable.

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Stakeholders weigh in on BsUFA IV enhancements

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