BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022

Regulatory NewsRegulatory News | 20 October 2016 |  By 

A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase.

FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the right balance between speeding the approval of new biosimilars while maintaining the same level of quality seen by approved biologics.

The agency has made clear that the biosimilars program so far has been far more scientifically and legally complex than expected, though Califf noted that hopefully the proposed BsUFA II package will alleviate some of those challenges.

“The goal is to submit a package of proposed recommendations to Congress by the end of the calendar year,” Califf added.

FDA has so far approved four biosimilars, the latest of which came 23 September, when the agency signed off on Amgen's Amjevita (adalimumab-atto), the first biosimilar version of AbbVie's blockbuster biologic Humira (adalimumab). More than 60 other biosimilar programs are in some stage of development.

What is BsUFA?

Originally enacted in 2012 for a period of five years, BsUFA is a law that authorizes FDA to collect fees from drug companies that submit marketing applications for certain biosimilars.

The current legislative authority for BsUFA expires in September 2017, and new legislation will be required for FDA to continue collecting biosimilar user fees.

BsUFA II Details

In terms of the changes between BsUFA I and II, Leah Christl, head of theTherapeutic Biologics and Biosimilars Staff (TBBS) in FDA’s Office of New Drugs, offered a thorough explanation of what’s to come.

The new user fee program plans to allow for additional communication between FDA review teams and biosimilar applicants in the form of presubmission meetings, mid-cycle communications and late-cycle meetings, while also adding 60 days to the review timeframe to accommodate for additional interactions.

In addition, when manufacturing facilities are not adequately identified, FDA says it may need to conduct inspections late in the review process, which can adversely impact FDA’s ability to complete application review within the performance goal timeframes.

Accordingly, under BsUFA II, FDA plans to extend the goal date for an original application or a supplement when there is a need to inspect a facility that was not included in a comprehensive and readily located list of manufacturing facilities.


FDA has seen an increasing number of Type 2 biosimilar development program (BPD) meetings under BsUFA I (these are the meetings to discuss a specific issue (e.g., proposed study design or endpoints) or questions where the FDA will provide targeted advice regarding an ongoing BPD program), and in some cases FDA has had to respond to sponsors in writing.


Christl noted that FDA occasionally denies a BPD meeting but provides a written response to the biosimilar sponsor, though there has never been a formal structure around such written responses.

Under BsUFA II, for biosimilar initial advisory and Type 2 meetings, sponsors may request a written response to questions rather than a face-to-face or teleconference meeting.

The new user fee proposal would also reduce the scheduling timeframe for biosimilar initial advisory meetings (such meetings are limited to a general discussion on whether a proposed product could be developed as a biosimilar), which will occur within 75 calendar days, instead of 90 days, from FDA’s receipt of the meeting request.

But for BPD Type 2 meetings, FDA will have more time for scheduling, with meetings occurring within 90 calendar days instead of 75, with phased-in goals: 80% of Type 2 meetings for FY2018 and 2019, and 90% in FY2020 through 2022.

Guidance and Capacity

In terms of new guidance coming down the pike, Christl referenced the following slide:


In addition, FDA plans to use additional user fees under BsUFA II to strengthen staff capacity, develop new guidance and regulations to clarify scientific criteria for biosimilar developers, deliver more timely information to the public to improve the overall understanding of biosimilarity and interchangeability, and deliver more information concerning the date of first licensure and each reference product’s exclusivity expiration date.

User Fees

FDA and industry have agreed that the BsUFA II user fee revenue amounts and fee amounts should be independent of the Prescription Drug User Fee Act (PDUFA) and based on BsUFA program costs.

The agency proposes to establish fees to generate a total of $45 million in user fee revenue for FY 2018.

However, FDA also proposes that it can adjust this amount when setting the user fee amounts to reflect an updated assessment of the BsUFA workload, though this adjustment cannot increase user fee revenue by more than $9 million.

Modifications of the BsUFA fee structure were highlighted by Josh Barton, operations research analyst at CDER, on Thursday, as he explained some of the changes that will occur over the next five years.  

For instance, BsUFA II will remove the supplemental fee and establishment fee for sponsors, establish an independent user fee structure and modify the product fee with a new provision that sponsors shall not be assessed more than five BsUFA program fees for a fiscal year per application.

And FDA proposes that the amount for each BsUFA fee cannot increase more than 25% from the respective FY 2018 fee until its capacity planning adjustment is effective.

Other details were offered on this slide:



Federal Register Notice


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