Luye Pharma Receives NMPA’s Approval of World First Boyoubei (biosimilar, denosumab) to Treat Postmenopausal Women with Osteoporosis
Shots:
- The NMPA has approved Boyoubei, a first denosumab biosimilar referencing Prolia/Xgeva for postmenopausal women with osteoporosis who are at a high risk of fractures. The product has been developed by Luye Pharma with its subsidiary Boan Biotech
- Boyobei is also being developed for markets outside of China, incl. the EU & US, and will seek marketing approval globally
- The evidence showed that Boyoubei was bioequivalent to the originator drug, the quality, safety, and efficacy of the two drugs are highly similar with no clinical difference. Patients treated with Boyoubei for 6mos. or 1yr. showed a higher BMD in the lumbar spine, hip, and femoral neck, lower levels of biochemical markers of bone turnover, incl. CTX & P1NP
Ref: Luye | Image: Luye
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