The US Food and Drug Administration (FDA) granted interchangeable biosimilar designation to denosumab-bnht (Bomyntra) for patients with multiple myeloma (MM) to prevent skeletal-related events, bone metastases from solid tumors, refractory hypercalcemia of malignancy, and unresectable giant cell tumor of bone, according to Fresenius Kabi, the manufacturer of denosumab-bnht.
The designation aligns with FDA draft guidance to simplify biosimilarity studies, reduce clinical testing, and ease interchangeability, allowing pharmacy substitution for biologics that drive 51% of US drug spending despite 5% of prescriptions, according to a press release from the FDA.
Since the Biologics Price Competition and Innovation Act (BPCIA) in 2010, the FDA has approved 76 biosimilars, including ones to treat various cancers.
“Fresenius Kabi is pleased to receive this interchangeable designation for… Bomyntra to create access for patients and healthcare professionals to important, high-quality therapies at a reduced cost,” said Sang-Jin Pak, MD, president of biopharma and member of the Fresenius Kabi management board, in a press release from the company.
