Biopharmaceutical firm Boan Biotech has announced that it has completed subject enrollment for a multinational Phase III study of its denosumab injections.
Known as BA6101 and BA1102, both drugs are biosimilars of Amgen’s drugs Prolia and Xgeva. Prolia is used in indications such as postmenopausal osteoporosis while Xgeva’s applications include the prevention of fractures in patients with multiple myeloma.
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Alongside this, the company has also held a meeting in Germany where it announced the results of a Phase I pharmacokinetic similarity study of BA6101.
The randomised study met the pre-specified acceptance criteria of bioequivalence against two variants of the drug, based on the 12 January press release.
The international comparative clinical Phase III study of BA6101 and BA1102 is taking place at sites across Europe, the United States and Japan.
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Dou Changlin, chief operating officer at Boan Biotech, said: “Publicly available data shows that Prolia and Xgeva achieved global sales of $3.63 billion and $2.01 billion respectively in 2022. It can be anticipated that the size of international markets for biosimilars of denosumab will be substantial.”
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By GlobalDataIn November 2022, BA6101 was launched in China under the trade name Boyoubei as a locally produced version of denosumab. In March 2023, the biologics license application of BA1102 was also accepted by China’s National Medical Products Administration.
Rainard Fuhr, the principal investigator of the Phase I pharmacokinetic similarity trial, , said: “Denosumab is used globally and plays an important role in treating related diseases. Developing denosumab biosimilars is important to meeting patient needs in clinical practice.
“We’re very excited to see the data presented by Boan Biotech, showing high-quality progress of the international clinical studies for BA6101, and we hope these two products can be launched as soon as possible, to provide quality treatments for patients and increase the accessibility of denosumab for them.”
In May 2023, Prolia originator Amgen showed findings from a real-world study that demonstrated that the drug was able to significantly reduce the risk of osteoporosis in postmenopausal women compared to the standard treatment of alendronic acid.
According to GlobalData’s Pharmaceutical Intelligence Centre, Prolia was estimated to have reached a total sales value of $4bn in 2023. The sales are expected to drop to $2.7bn by 2029 as more biosimilar versions of Denosumab enter the market.
GlobalData is the parent company of Clinical Trials Arena.
