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Boan Biotech Begins International Phase III Trial Of Denosumab Biosimilars

One Product Is Already Approved For Marketing In China

 
• By Chloe Kent

Having already launched one of its denosumab biosimilar products in China, Boan Biotech has now commenced an international Phase III study to secure approval in Europe, the US and Japan.

US, EU and Japanese flags
The international study has been initiated in Europe, the US and Japan • Source: Shutterstock

Following the approval of its Prolia (denosumab) biosimilar in China late last year, Luye Pharma Group, Ltd. subsidiary Boan Biotech has now enrolled the first subject in an international multi-center Phase III clinical study for its two denosumab candidates, BA6101 and BA1102.

BA6101 was approved in China in November 2022, where it is marketed as Boyoubei, making it the world’s first ever approved Prolia biosimilar. (Also see "Luye Claims A First With Chinese Denosumab Approval" - Generics Bulletin, 17 November, 2022

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