Eye on Pharma: NeuClone Reveals It Is Developing Pertuzumab Biosimilar

Australian drug developer NeuClone has disclosed that it is currently developing a proposed pertuzumab biosimilar referencing Perjeta.

Pertuzumab is an IgG1 humanized monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2), and it is intended to be used in combination with trastuzumab (a biosimilar of which NeuClone is also developing) for the treatment of HER2-positive early or metastatic breast cancer.

The pertuzumab product is being developed in partnership with the Serum Institute of India as part of a joint development project that includes 10 biosimilar products intended for the global marketplace.

“We believe biosimilar combination therapies referencing Perjeta and Herceptin represent an exciting development in the future of biosimilars,” said Noelle Sunstrom, PhD, CEO of NeuClone, in a statement. “Current combination treatments of [monoclonal antibodies], while often clinically superior to monotherapies, are extremely expensive when available. We are determined to dramatically expand the number of patients able to receive these life-changing combination therapies by offering lower-priced biosimilars of both [monoclonal antibodies].”

The eventual approval of a pertuzumab biosimilar has the potential to greatly improve access to treatment for many patients for whom the high-cost brand-name Perjeta is out of reach. In August 2018, the United Kingdom’s National Institute for Health and Care Excellence (NICE), the nation’s health technology assessment body, rejected pertuzumab for routine use on the basis of cost, even for patients whose breast cancer had a high risk of recurrence. According to NICE, biosimilar trastuzumab, which is already available in the United Kingdom, would reduce the overall cost of treatment, but even with those deep discounts, using the brand-name pertuzumab was unlikely to be cost-effective for use under the National Health Service.

Among the other biosimilars being developed by NeuClone are proposed ustekinumab (Stelara), palivizumab (Synagis), denosumab (Prolia, Xgeva), and adalimumab (Humira) products.