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.”…
