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WHEN CHOICE ARRIVES: Competition & Consequences

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Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Here are the top 5 biosimilar articles for the week of April 7, 2025.

The Top 5 Biosimilar Articles for the Week of April 7

Articles

Biocon Biologics expands its oncology biosimilar roster after gaining FDA approval for Jobevne (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).

FDA Approves Biocon Biologics' Bevacizumab Biosimilar

Teva and Samsung Bioepis have launched Epysqli, a cost-saving Soliris biosimilar, offering a 30% discount and new hope for patients with rare, life-threatening hematologic conditions.

Teva and Samsung Bioepis Launch Biosimilar Epysqli 

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.

BioRationality: Commemorating the 15th Anniversary of the BPCIA

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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

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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