FDA’s Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years

Posted 14 March 2016 By Zachary Brennan


A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies continue to seek more meetings with FDA on specific issues and targeted advice.

As of 30 September 2015, the report says there are 57 programs participating in the biosimilar product development program (up from 33 in FY 2013 and 48 in FY 2014), and a total of seven Biologics License Applications (BLAs) have been submitted under section 351(k) of the Public Health Service Act (known as 351(k) BLAs), one of which (Zarxio) was approved in March 2015.

The purpose of the new report, released this week, is to provide an independent study of the workload volume and full costs associated with FDA’s biosimilar program so far, primarily performed by FDA’s Center for Drug Evaluation and Research (CDER), and as required by a section of the Food, Drug, and Cosmetic Act (FD&C Act) that was amended by the Biosimilar User Fee Act (BsUFA).

The study, performed by Eastern Research Group (ERG), estimates both the volume of biosimilar program work components and the workload volume and full costs (direct and indirect) of this work.

Work Breakdown

In total, ERG estimates that FDA has spent $81.7 million on biosimilars-related work over the first three fiscal years of the program.

The analysis also estimates that 295 full-time equivalents (FTEs), which are units indicating the workload of an FDA employee, have been spent by FDA on biosimilar-related work from the start of FY 2013 through FY 2015.

The largest category of work for FDA has been for biosimilar development program activities (84.8 FTEs), which includes meetings between industry and FDA. In that category, the most-frequently requested and scheduled meeting so far is the BPD Type 2 meeting, which is a meeting 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.

The number of BPD Type 2 meetings have more than doubled from 21 in FY 2013 to 48 in FY 2015.

However, other types of meetings between industry and FDA have actually decreased in number even as biosimilar application submissions have risen. For instance, FDA and industry scheduled three biosimilar initial advisory meetings in FY 2013, nine in FY 2014, but then only two in FY 2015. Similarly, six BPR Type 3 meetings, which are for in-depth data review and advice on an ongoing program, were scheduled in FY 2013, then nine were scheduled in FY 2014, but only one was scheduled in FY 2015.

Policy work (30.3 FTEs) and 351(k) BLA reviews (25.9 FTEs) were the second- and third-largest categories of work, respectively. Most of the FTEs for 351(k) BLA review activities were incurred in FY 2015, ERG adds.

FY 2015 was also the first year that FDA began devoting resources to continuing education courses on biosimilars, as well as focus groups and day-long seminars.

Other Findings, Comparisons

ERG’s total cost estimates represent 83 to 105 percent of the values that are reported by FDA in its BsUFA financial reporting. And ERG’s FTE estimates are between 88 and 105 percent of the FDA reported FTEs.

The difference in the two estimates are largely because FDA’s estimate of FTEs in its financial report is calculated by multiplying the number of total FTEs for each CDER office by a percentage reflecting biosimilars work for that office.

ERG’s estimates, on the other hand, are built from projections based on the time reporting data and interviews with FDA staff on time spent performing biosimilars work.

The report notes that there are some limitations related to ERG’s estimates, particularly as FDA interviewees may not fully remember all work performed and FDA’s time reporting data is based on only a two-week sample each quarter and is thus subject to sampling error.

Review of Biosimilar Biologic Product Applications: Study of Workload Volume and Full Costs

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Categories: Biologics and biotechnology, Clinical, Compliance, Due Diligence, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, CBER, CDER

Tags: biosimilars, FDA work on biosimilars, 351(k), BLA, FDA FTEs

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