FDA touts success and challenges in biosimilar development

Regulatory NewsRegulatory News | 10 November 2021 |  By 

A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the program in the oncology space, with less activity in other treatment areas. The costly and lengthy process of getting biosimilars approved is also a deterrent to wider uptake.
Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), made these observations in her update on the biosimilar development program in her CDER keynote address at the 8 November meeting of the Association for Accessible Medicines’ (AAM) GRx+Biosim conference, which was held virtually this year.
Janet Woodcock, FDA’s acting commissioner, also promoted the agency’s role in encouraging the development of generic and biosimilar drugs, asserting that that these drugs provide huge cost savings to consumers.
More biosimilar approvals
Corrigan-Curay called the biosimilar product development program a “great success” in terms of approvals, uptake in certain sectors, and engagement.
She said that as of November, FDA has approved 31 biosimilars for 11 reference products. This figure is up from the 29 biosimilars approved in May 2021 (RELATED: Woodcock cites ‘vigorous interest’ in biosimilar development, Regulatory Focus, 28 May 2021).
She said that these approvals include two interchangeable products. The first  interchangeable biosimilar wasMylan’s Semglee (insulin glargine-yfgn) followed by Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). Interchangeable biosimilar products may be substituted at the pharmacy level for their reference products without prescriber intervention, much as generic drugs may be substituted at the pharmacy level for reference-listed drugs. (RELATED: Cylezo approved as interchangeable biosimilar with Humira, Regulatory Focus 18 October, 2021)
The Semglee approval, she said, “represented a lot of research and coordination across multiple offices in CDER.”
FDA is also seeing an “increasing uptake of this program in oncology,” added Corrigan-Curay.
The agency also approved a growing number of biosimilar manufacturing supplements: thirty-two were approved in 2020, an increase over the 22 approved in 2019 and the six approved in 2018.
Another positive signal is that FDA is also hosting an increasing number of meetings with sponsors on their biosimilar development programs; the topic at many of these meetings is discussing new products. The number of meetings grew from 46 meetings in 2018, to 77 in 2019 and 68 in 2020. She called the 77 meetings held in 2019 a “peak.”
Biosimilars challenges noted
She said that while there is more uptake of the program in the oncology space, adoption is less prevalent in other treatment areas.
The costly and lengthy process of getting biosimilars approved is also a deterrent to wider uptake.
Although 31 biosimilar products have been approved, only 20 are currently being marketed. An array of market and legal obstacles, including “patent thickets” set up by firms holding approvals for originator biosimilars, has contributed to the slow market entry of biosimilars.
Lastly, she noted that the biosimilar product development process continues to be “costly and lengthy.”
Woodcock highlights cost savings

In her remarks, Janet Woodcock, FDA's acting commissioner, said that despite these obstacles, the biosimilars program has been succesful in reducing drug costs to consumers.
“Even in the face of a number of challenges in the biosimilar space, new launches and improved utilization led biosimilar savings last year to grow by more than three times the $2.5 billion saved in 2019, with an especially high impact in oncology,” said Woodcock.
Woodcock also asserted that the overall savings impact of both the generics and biosimilars program on consumers has been “enormous.” Last year, she said, “Americans saved $338 billion by using generics and biosimilars. That’s an increase of $18 billion from 2019.”

“While our agency does not play a direct role in drug pricing, we can — by encouraging development of lower-cost generic and biosimilar products — support competition in the health care market,” added Woodcock.
BsUFA III commitments
In other areas, Corrigan-Curay said that the agency is “looking forward” to discussing reauthorizing the Biosimilar User Fee Amendments program (BsUFA III). FDA released its commitment letter on the program’s reauthorization in a public meeting earlier this month. (RELATED: BsUFA III commitment letter details FDA, industry goals for biosimilars program, Regulatory Focus 21 September 2021)
The letter details the introduction of new supplement types and expedited review timelines, sets forth ways to enhance communication and feedback during the biosimilar development process, and promotes implementing best practices in communication during application review.
Agency has met BAP deliverables
Corrigan-Curry also noted the that the agency has also met the goals that were set in the Biologics Action Plan to remove barriers to biosimilar development. These include:
  • The release of a draft question and answer guidance on biosimilar development, released in November 2020 with a final Q&A guidance issued in September 2021.
  • FDA’s public workshop on the current and future role of pharmacodynamic biomarkers in improving the efficiency of biosimilar product development and approval. The meeting was held in September 2021.
  • An update to the Purple Book to include patent information. Corrigan-Curay noted that the update was meant to make the Purple Book “more accessible.” She said that the book is “now electronic and searchable.”
AAM GRX biosimilars meeting


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Tags: biosimilars, FDA

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