USA – Biosimilar facilities usually get onsite inspections

A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as these products are relatively new and involve novel manufacturing processes. She also noted that the facilities making these products are generally new to biosimilar manufacturing.

Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), made the remarks at the Association for Accessible Medicines’ (AAM) GRx+Biosim conference in Bethesda, MD on Monday.

In the biosimilar preapproval space, the agency continues to see “inspection challenges” at sites with prior inspectional and marketing histories that are seeking their first approval of a biologics license application (BLA), according to Corrigan-Curay and other officials who spoke at the event.

The officials also discussed some of the major enhancement in reviewing biosimilars present in the third iteration of its Biosimilar User Fee Amendments (BsUFA III) program, which will run from FY 2023-2027. They also discussed some of the ongoing research in the biosimilar field and provided an update on upcoming guidances to look for affecting the industry…