FDA officials tout steady growth in biosimilar program, enhancements under FDORA

US Food and Drug Administration (FDA) officials touted “steady growth” in the total number of biosimilar products since the program’s inception, with 40 approvals and another 102 applications under review at the agency’s annual Regulatory Education for Industry (REdI) conference on Monday.

At the meeting, Stacey Ricci, director of the scientific review staff in the Office of Therapeutic Biologics and Biosimilars (OTBB) in the Center for Drug Evaluation and Research (CDER), and other officials provided an update on biosimilar approvals, discussed a new legislative push to stimulate the biosimilar program thanks to the recently enacted Food and Drug Omnibus Reform Act (FDORA), and reiterated some of the changes under the third Biosimilar User Fee Amendments (BsUFA III) program.

Of the 40 biosimilars approved for 11 different reference products since 2015, four are interchangeable biosimilars, with 29 products being marketed in the US, said Ricci. These approved products cover a wide range of therapeutic diseases and conditions, including the side effects of chemotherapy, hematologic malignancies, autoimmune diseases, Crohn’s disease, ulcerative colitis and macular degeneration.

Another 102 biosimilar products are in “active” development programs, Ricci said, and she expects that some of these products will be approved this year, which “should increase biosimilar uptake and availability nationwide.”

FDORA

Ricci also said that new authorities in FDORA gave a boost to the biosimilars program. The new law specifies that holders of biologics license applications (BLAs) report to FDA the marketing status of their product by 27 June to ensure that their products listed in the Purple Book are still available to sale.

The law also allows analytical studies to replace animal studies for toxicity assessment; it clarifies first interchangeable exclusivity (FIE) by specifying that if several first interchangeable products are approved on the same day, they each qualify for a FIE. It clarifies that when a subsequent application for an interchangeable product is blocked by an FIE, FDA can approve that application as a biosimilar.

Goals for releasing guidelines

Ricci also described the agency’s timeframe for releasing guidance documents to comply with BsUFA III. These include:

The release of a revised draft guidance on formal meetings between FDA and sponsor will be issued in September 2023.
A guidance on classifying supplements to a licensed 351(k) BLA for purposes of determining review timelines by 30 September 2023.
A guidance on labeling for interchangeable biosimilar products by 30 September 2023.
A guidance on the use of alternative inspection tools by 30 September 2023
An update of relevant guidance covering best practices in communicating with applicants by 31 October 2023.
A guidance on how sponsors should leverage use-Related Risk Analyses (URRA) studies to identify the need for risk mitigation strategies and the design of human factors (HF) validation studies for biosimilar device combinations by 30 September 2024. Based on a URRA, a sponsor may propose that a HF validation study is not needed to support the safe and effective use of a biosimilar biologic-device combination product.
A guidance on reporting categories for post-approval manufacturing changes by 30 September 2024.

ReDi meeting

FDA officials tout steady growth in biosimilar program, enhancements under FDORA

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