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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: denosumab

Cipla expands biosimilar partnership with Alvotech for ANZ

March 2, 2021

Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).

Vizient releases Pharmacy Market Outlook

January 27, 2021
Health care performance improvement company Vizient releases its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.

Celltrion submits IND for denosumab biosimilar

January 15, 2021
Celltrion announces it has submitted an investigational new drug application for Ph III trials of CT-P41 (proposed denosumab biosimilar).

Samsung commences Ph III denosumab trials

December 14, 2020

Samsung Bioepis announces it has commenced Ph III trials of SB16 (proposed denosumab biosimilar) in women with postmenopausal osteoporosis.

Novartis provides updates on Sandoz biosimilar candidates

November 24, 2020

Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it  has planned launches for biosimilar adalimumab and natalizumab in 2021-2023 and denosumab in 2024-2026.

Samsung Bioepis commences Ph I denosumab trials

November 10, 2020

Samsung Bioepis announced it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).

Samsung Bioepis commences Ph I denosumab trials

November 10, 2020

Samsung Bioepis announces it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).

Shanghai Henlius Biotech commences Ph I denosumab trials

November 9, 2020

Shanghai Henlius Biotech announces it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).

Shanghai Henlius Biotech commences Ph I denosumab trials

November 9, 2020

Shanghai Henlius Biotech announces it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).

New denosumab study demonstrates correlation between delayed injections and osteoporotic fractures

August 27, 2020

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.

Celltrion announces Ph I denosumab trials to commence in September 2020

August 14, 2020

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

BeiGene launches Xgeva® in China

June 30, 2020

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.

China’s NMPA approves Henlius’ IND

May 27, 2020

Shanghai Henlius Biotech announces that China’s National Medical Products Administration has approved its IND application for HLX14, a proposed denosumab biosimilar. 

JHL Biotech commences dosing in Ph I denosumab trials

May 18, 2020

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

China’s NMPA accepts Henlius’ denosumab NDA

March 9, 2020

Shanghai 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.

Sandoz commences patient enrolment in Ph I/III denosumab trials

July 23, 2019

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.

Shanghai Biomabs commences Ph I denosumab trials

July 1, 2019

Shanghai Biomabs commences Ph I trials of biosimilar denosumab candidate.

Qilu commences Ph I denosumab trials

August 20, 2018

Qilu commences Ph 1 trials of biosimilar denosumab candidate.

Neuclone discloses development of biosimilar denosumab

January 8, 2018

Australia’s Neuclone discloses the 5th product in its pipeline is biosimilar denosumab, which is at the pre-clinical stage.

AryoGen releases results of Ph III denosumab trials

September 26, 2017

AryoGen releases results of Phase III trials of biosimilar denosumab product.