Boan Biotech completes enrolment for phase 3 study of Denosumab
Betsy Goodfellow | January 15, 2024 | News story | Research and Development | Boan Biotech, Pharmacy, biosimilar, clinical trial, denosumab
Boan Biotech has announced that it has completed subject enrolment for its international multicentre comparative phase 3 clinical trial of the company’s Denosumab injections (BA6101 and BA1102).
The study will take place in Europe, the US and Japan, with a meeting having recently been held in Germany to share results from a phase 1 pharmacokinetic similarity clinical study for BA6101.
BA6101 and BA1102 are both biosimilars to the original Denosumba Injections Prolia and Xgeva, respectively. Prolia is often used for the treatment of osteoporosis, while Xgeva is used to treat diseases such as multiple myeloma and bone metastasis of solid tumours, giant cell tumours of bone and hypercalcemia.
Dr Dou Changlin, president of research and development and chief operating officer at Boan Biotech, commented: “Publicly available data shows that Prolia and Xgeva achieved global sales of $3.63bn and $2.01bn respectively in 2022. It can be anticipated that the size of international markets for biosimilars of denosumab will be substantial. We will strictly follow the Good Clinical Practice (GCP) requirements to conduct the international phase 3 study, and will also continue to build a system complying with the current Good Manufacturing Practices (cGMP) required by the authorities in Europe, the US and Japan, to prepare for submission of the marketing authorisation applications in those jurisdictions.”
Betsy Goodfellow
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