Sandoz Enrolls First Patient in Study of Proposed Denosumab Biosimilar, GP2411

Sandoz announced today that it has enrolled its first patient in a combined phase 1 and phase 3 study of its proposed denosumab biosimilar versus EU-authorized Prolia.

Denosumab, a monoclonal antibody that inhibits the RANKL protein and thereby decreases the production of osteoclasts, is indicated for a number of conditions, including osteoporosis in postmenopausal women, increased fracture risk in men, a treatment-induced bone loss, among others.

“People with the bone disease osteoporosis are more likely to fracture or break a bone, causing pain and restriction of mobility, which can be extremely debilitating,” said Florian Bieber, global head of development at Sandoz, in a statement announcing the trial. “As we progress our development program for proposed biosimilar denosumab, we believe it gives patients hope for early and expanded access to advanced biologic medicines, which may change the course of their disease.”

The study, ROSALIA, is a multicenter, randomized, parallel-arm, double-blind study with a total duration of up to 82 weeks. The drug maker plans to enroll approximately 522 postmenopausal patients with osteoporosis for 2 treatment periods.

In the first period of 52 weeks, patients will be randomized to receive 2 doses of either GP2411 or the EU-authorized reference product.

In the second treatment period, from week 52 to week 78, patients who received the reference denosumab in the first period will be rerandomized either to continue to receive the reference or to switch to GP2411. All patients in the biosimilar group will continue with a third dose of GP2411.

The study’s primary end points include percentage change in lumbar spine bone mineral density, and the drug maker expects to complete the study by June 2022.

The reference drug, Prolia, has been a strong seller for Amgen, the innovator behind denosumab. In first quarter 2019 financial results, Amgen said that the drug had brought in $390 million in the United States and $202 million in the rest of the world. Those sales were up 20% year over year, said the company, driven by higher unit demand.

Other biosimilar developers targeting denosumab include Australian drug maker NeuClone; the company announced in early 2018 that it had entered early-stage development of a proposed biosimilar.