Biosimilars Program About to Explode: Woodcock
CDER director Janet Woodcock is very concerned that the agency’s biosimilars program is going to “explode” with many high-profile applications potentially being submitted without adequate staff to process and review them. Testifying before a House Energy and Commerce health subcommittee hearing 2/4, Woodcock said that currently the Center has 59 proposed biosimilar products that reference 18 different biologic innovator products enrolled in its Biosimilar Product Development Program. Under the program, CDER holds development-phase meetings and provides written advice for ongoing development programs. “The number of meeting requests increased 81% from 32 in FY 2013 to 58 in FY 2015,” she said. “The number of scheduled meetings also increased 67% from 30 in FY 2013 to 50 in FY 2015.”
Addressing questions by ranking member Frank Pallone (D-NJ) about additional appropriations needed by FDA, Woodcock said Congress has not appropriated any direct funding for the biosimilars program and currently it is being supported by a modest user fee program. “We have begun to collect more money in user fee programs,” she said, noting that in FY 2013 $6 million was collected, FY 2014 $13 million, and in FY 2015 $23.8 million. “We are beginning to build the program, and as new biosimilars come onto the market perhaps we will have a more robust funding for the program.” She cautioned that the agency is seeing in the near future multiple entries potentially for the top biologics, adding that “I am concerned that we will not have staff because we are always waiting to catch up.”
Rep. Joe Barton (R-TX) asked Woodcock about the criticisms the agency is receiving over not producing a biosimilar labeling guidance yet. She said a draft guidance is being prepared and will be released later this year. “We understand the issues and I’ve been personally involved in many discussions about this, ... and we will put something out that people can comment on.” She noted that that additional guidance on interchangeability and statistical approaches on analytical similarity data used to support a biosimilarity demonstration are forthcoming as well.
Woodcock’s testimony noted that FDA is working to recruit additional staff and has continued to allocate increasing resources for the biosimilar regulatory review program. “While the FTE expenditure in fiscal years 2013 and 2014 were relatively equal, the FTE expenditure in the first two quarters of FY 2015 was equivalent to the total expenditures in the previous two fiscal years,” she said. “As projected, FDA expended more FTEs in FY 2015 than previous years. The increase in FTE expenditure is a direct reflection of the change and increase in workload in FY 2015.”
Woodcock said that since the program began, five companies have publicly announced submission of eight biosimilar BLAs for proposed products. So far, only one BLA from Sandoz has been approved for Zarxio (filgrastim-sndz), a biosimilar product referencing Amgen’s anemia therapy Neupogen. On 2/9, she said, FDA’s Arthritis Advisory Committee is scheduled to hold a meeting to discuss a proposed biosimilar to Remicade (infliximab).