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Boan Biotech Nears Denosumab Registration After Phase III Enrollment Completion

Biosimilar Developer Is Nearing The Finish Line As Key Patents Are Set To Expire In 2025

 
• By Urtė Fultinavičiūtė

Completion of the Phase III trial may lead Boan Biotech to international registrations of denosumab, a market worth over $5.6bn globally.

Two People Participating In A Clinical Trial
Boan Biotech’s denosumab biosimilar BA6101 is already approved in China • Source: Shutterstock

Boan Biotech has completed participant enrollment in its international Phase III trial investigating its proposed denosumab biosimilars, BA6101 and BA1102. While the China-based biotech did not disclose when it expects to finish the study, the trial completion may lead to license applications for both injections in Europe, the US, and Japan.

The biotech has already entered one market with BA6101 as the drug was approved by China's National Medical Products Administration in November 2022, where it is marketed as Boyoubei. (Also see "Luye Claims A First With Chinese Denosumab Approval" - Generics Bulletin, 17 November, 2022

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