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BIOSIMILAR APPROVALS

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

Articles

Panelists at an IGBA Global Biosimilars Week webinar detailed worldwide access gains and adoption barriers.

IGBA's Global Biosimilars Week Panel Spotlights Value of Access

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.

Biosimilar market share averaged 40.7% across 27 European countries by mid-2024, with gain-sharing, switching, and quotas linked to higher uptake.

Biosimilar Uptake in Europe Reached 40.7%, With Wide Country Gaps

Highest biosimilar uptake occurred where policymakers combined multiple supply- and demand-side measures or ran coordinated national tendering.

National Tendering, Combined Policies Linked to Highest Biosimilar Uptake

A prospective Italian cohort found procurement-driven switching from reference ustekinumab to biosimilars preserved remission and safety in Crohn disease.

Ustekinumab Biosimilar Switch Holds Up in Crohn Disease

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

Teva's Robert Cook, PhD, explains the clinical data, interchangeability, and supply strategy behind its Degevma and Ponlimsi biosimilars.

Inside Teva's Denosumab Biosimilar Strategy: Robert Cook, PhD

The FDA approved Teva's Degevma, a denosumab biosimilar to Xgeva for cancer-related bone disease, rounding out its Xgeva/Prolia portfolio.

Teva Completes Denosumab Biosimilar Pair With FDA Nod for Degevma

Sandoz's Edward Li explains how biosimilar denosumab pricing could reshape cost-effectiveness, payer access, and gaps in osteoporosis care.

Biosimilar Denosumab Could Reshape Access, Costs in Osteoporosis Care: Edward Li, PharmD

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

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

Denosumab Biosimilar KN012 Matches Reference Drug in Phase 3 Osteoporosis Trial

Robert Cook, PhD, of Teva explains how analytical characterization and PK data will shape its next biosimilar program.

How FDA's PK Guidance Shapes Teva's Next Biosimilar Program

 to streamline the pharmacokinetic (PK) testing required in biosimilar development, including allowing PK studies to use a comparator product approved outside the US when scientifically justified, a change that FDA Commissioner Marty Makary, MD, MPH, said could cut PK study costs by up to 50%.

The guidance arrives as Teva Pharmaceutical Industries completes its pair of denosumab-adet biosimilars (Degevma, Ponlimsi), referencing Xgeva and Prolia (Amgen), respectively. Teva announced the 

, its Xgeva biosimilar, on September 28, 2026, about 6 months after the approval of Ponlimsi, its Prolia biosimilar. The Degevma approval covers all of Xgeva's indications and was based on a totality of evidence, including analytical and clinical data demonstrating efficacy, safety, and immunogenicity similar to the reference product.

"We completely support the US FDA's view of relaxing the regulatory framework for biosimilars," Robert Cook, PhD, head of generics R&D and senior vice president of global technical development at Teva, said in an interview with The Center for Biosimilars. "We do think it will catalyze the uptake or adoption of biosimilars across the market and reduce health care costs as a result."

Cook said the efficacy data at the primary and secondary end points were likely the most compelling part of Teva's denosumab clinical program.

"But if you take that data together with all of the other clinical efficacy studies that other companies have run across the biosimilar industry, it's not offering a lot of incremental benefit over all of the analytical characterization of work that goes on," he explained.

Industry and regulatory working groups have pushed to move away from clinical efficacy studies and toward analytical characterization, Cook said, a shift that puts industry and regulators "in a good place" and provides better access to medications at affordable prices.

For Teva, that means future programs will pair analytical characterization with PK studies that confirm equivalent blood levels and exposure and test for markers of immunogenicity. It isn't a full clinical efficacy study, Cook said, but it is "a considerable clinical safety package."

"What does it mean for our next biosimilar program?" Cook said. "You have really strong characterization and analytical characterization using state-of-the-art equipment across a lot of expertise…Between the analytical characterization and that PK—that's how we'd approach the next biosimilar."

1. Al-Faruque F. FDA proposes major change to biosimilar PK study requirements. Regulatory Affairs Professionals Society. March 2026. Accessed October 8, 2026. 

https://www.raps.org/news-and-articles/news-articles/2026/3/fda-proposes-major-change-to-biosimilar-pk-study-r

2. McCrear S. Teva completes denosumab biosimilar pair with FDA nod for Degevma. CFB. September 29, 2026. Accessed October 8, 2026. 

https://www.centerforbiosimilars.com/view/teva-completes-denosumab-biosimilar-pair-with-fda-nod-for-degevma

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