Eye on Pharma: NeuClone Developing Denosumab Biosimilar

Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva). Denosumab, a RANK ligand inhibitor, is used in the treatment of osteoporosis, as well as treatment-induced bone loss, among other indications. The proposed denosumab molecule brings NeuClone’s biosimilar pipeline to 5 products (it is also developing biosimilars to trastuzumab, ustekinumab, adalimumab, and palivizumab).

In a statement, NeuClone’s CEO, Noelle Sunstrom, PhD, said of the early-stage development of this drug, "We are dedicated to broaden[ing] patient access to biological medicines globally by making affordable products of the highest quality. At all stages of development, we are focused on global approval from the most stringent regulatory bodies including the US and European agencies."

The statement went on to describe its product as a potential “early market entrant” for denosumab biosimilars. If eventually approved, NeuClone’s product would compete for a share of substantial sales; Amgen earned $3.5 billion from the branded drug in 2016, and NeuClone predicts that global sales of the treatment could reach $5.6 billion by 2022.

Other biosimilar developers aiming for a share of the denosumab market include AryoGen Pharmed, which is currently recruiting participants in a phase 3 study of its proposed biosimilar in patients with osteoporosis, and BioXpress Therapeutics, which reports that denosumab is a “future product” for development.

Meanwhile, Amgen, maker of the reference denosumab, has secured a new indication for its innovation. The FDA last week approved the drug maker’s supplemental Biologics License Application (sBLA) for the reference drug to expand the approved indication for the prevention of skeletal-related events to include patients who have multiple myeloma (MM). The approval of the sBLA was based on data from a phase 3 study conducted in 1718 patients. The study met its primary endpoint of demonstrating the noninferiority of denosumab to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with MM.