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Cameron Santoro is an associate editor for The Center for Biosimilars

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Here are the top 5 biosimilar articles for the week of March 31, 2025.

The Top 5 Biosimilar Articles for the Week of March 31

Articles

The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.

Ranibizumab Biosimilar Shows Reduced Efficacy vs Aflibercept in nAMD

Bevacizumab biosimilars Mvasi and Zirabev provided cost savings for metastatic colorectal cancer (mCRC) treatment without compromising effectiveness.

Bevacizumab Biosimilars Reduce Costs While Maintaining Survival Outcomes in mCRC

As the biosimilar industry celebrates a decade of growth, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.

Biosimilars Gastroenterology Roundup: March 2025

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Clinical

Bio-Thera Solutions began a phase 1 trial for its mepolizumab biosimilar candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

Biosimilar Business News Recap: Mepolizumab Study; New Licensing Deal; Hukyndra Launches in Switzerland

Recently, the US got 2 new biosimilars on the market, a bevacizumab and an interchangeable ranibizumab; Amneal Pharmaceuticals filed for marketing authorization in Europe; and Sandoz released positive results for a denosumab candidate.

Eye on Pharma: 2 US Launches, an EMA Filing, and Denosumab Results

Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis. 

Phase 3 Study of Amgen Biosimilar to Eculizumab Meets Primary End Points

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

Biosimilar natalizumab demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in patients with relapsing-remitting multiple sclerosis (RRMS), supporting its potential as a cost-effective treatment option.

Biosimilar Natalizumab-sztn Shows Comparable Efficacy and Safety to Tysabri in RRMS

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

FDA Approves Third Pair of Denosumab Biosimilars

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).

EC Approves Celltrion Denosumab, Aflibercept Biosimilars

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.

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