Prolia/Xgeva® | Denosumab | Amgen

10 Nov 20 | All | Samsung Bioepis | Samsung Bioepis announces it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).

 

09 Nov 20 | All | Shanghai Henlius Biotech | Shanghai Henlius Biotech announces it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).

 

27 Aug 20 | All | All | Rheumatology Advisor reports a study sponsored by China's National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation demonstrates that delayed administration of subsequent denosumab doses by greater than 16 weeks is associated with increased risk for vertebral fracture. This risk was observed in both the short delay (4-16 weeks) and the long delay (>16 weeks) groups. Additionally, there was a significant correlation between delayed subsequent injections and major osteoporotic fractures.

 

14 Aug 2020 | All | Celltrion | Korea Biomedical Review reports that Celltrion will commence Ph I clinical trials of CT-P41 (biosimilar denosumab candidate) in September.

 

30 June 2020 | CN | BeiGene | BeiGene announces its has begun commercialising Xgeva® (denosumab) in China. Xgeva® was developed by Amgen, and is the first of the products to be commercialised by BeiGene under a January 2020 agreement.

 

27 Jun 2020 | CN | Shanghai Henlius Biotech | Henlius Biotech announces the Investigational New Drug application for HLX14 (biosimilar denosumab) has been approved by China's NMPA for the treatment of postmenopausal osteoporosis.

 

27 May 2020 | CN | Henlius Biotech | Henlius Biotech announces that China's National Medical Products Administration has approved its IND application for HLX14, a proposed denosumab biosimilar. 

 

18 May 2020 | AU | JHL Biotech | JHL Biotech announces that the first group of subjects in the Australian randomised Ph I trials of JHL1266 (proposed denosumab) have been dosed.

 

09 Mar 2020 | CN | Henlius | Henlius Biotech announces China's National Medical Administration had accepted its Investigational New Drug application for HLX14 (denosumab). HLX14 is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

 

23 Jul 2019 | All | Sandoz | Sandoz announces commencement of patient enrolment in Ph I/III trials of proposed biosimilar denosumab. A total of 520 osteoporosis patients will be enrolled in the 52 week study.

 

01 Jul 2019 | All | Shanghai Biomabs | Shanghai Biomabs commences Ph I trials of biosimilar denosumab candidate.

 

20 Aug 2018 | All | Qilu | Qilu commences Ph 1 trials of biosimilar denosumab candidate.

 

08 Jan 2018 | All | Neuclone | Australia's Neuclone discloses the 5th product in its pipeline is biosimilar denosumab, which is at the pre-clinical stage.

 

26 Sep 2017 | All | AryoGen | AryoGen releases results of Phase III trials of biosimilar denosumab product. 

 

 

 

 

 

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Biosimilars Bulletin 

November 9, 2020

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