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Brooke McCormick is an assistant editor for 

Articles

Analytical characterization supports monoclonal antibody biosimilar approvals and may reduce clinical testing needs, researchers found.

Analytical Characterization Supports Confidence in Monoclonal Antibody Biosimilars

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Biosimilar denosumab cleared a $150,000 per QALY cost-effectiveness threshold against bisphosphonates for high-risk PMO, but not always at $100,000.

Biosimilar Denosumab Shows Cost-Effectiveness Over Bisphosphonates in PMO

Laura Joszt, MA, is the vice president of content for the managed care and pharmacy brands at MJH Life Sciences

. She has been with MJH Life Sciences since 2011.

Laura has an MA in business and economic reporting from New York University.

KN012 achieved BMD equivalence with US-approved denosumab in postmenopausal women in China. 

Denosumab Biosimilar KN012 Matches Reference Drug in Phase 3 Osteoporosis Trial

A 50-patient study found sustained platelet recovery and low thrombotic microangiopathy rates through 52 weeks of biosimilar therapy, with favorable safety.

Eculizumab Biosimilar Shows Durable Benefit in Long-Term aHUS

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.

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Content was developed independently by The Center for Biosimilars

In this episode, The Center for Biosimilars delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), which share the nonproprietary name of denosumab-bbdz. These products were approved in March 2024 and although they are the same drug, the different brand names correspond with different indications: Wyost is used for musculoskeletal issues related to bone metastases and Jubbonti is used for osteoporosis and patients with a high risk of fracture.

We have 2 esteemed guests to talk to us about how the osteoporosis treatment landscape is developing and how these new products will help expand access to denosumab treatment: Colin C. Edgerton, MD, a rheumatologist at Articularis Healthcare Group and a member of the American College of Rheumatology ultrasound task force, and Jeffrey Curtis, MD, MS, MPH, a professor, rheumatologist, and epidemiologist at the University of Alabama at Birmingham and a former member of the FDA Arthritis Advisory Committee.

To learn more about the approval of denosumab-bddz, 

To watch Curtis and Edgerton speak on the approval of denosumab-bddz and osteoporosis treatment, 

To learn more about the ROSALIA study (NCT05405725), 

Extra content: To read more about the Biosimilars Council position paper on how to improve biosimilar development, 

In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.


Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved

A romosozumab biosimilar showed comparable sclerostin binding and bone-signaling potency to the reference product despite disulfide isoform differences.


Romosozumab Biosimilar Matches Reference in Functional Testing Despite Disulfide Differences

Phase 3 data show denosumab biosimilar KN012 matches Prolia for BMD gains and safety, potentially expanding affordable osteoporosis care.

Biosimilar Denosumab Matches Reference Drug for Bone Density in Chinese Women

Evidence shows biosimilars switching in ankylosing spondylitis maintains disease control with biologics, cuts costs, and highlights nocebo risks.

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