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Articles

In a phase 2 study, the addition of HLX22, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in untreated HER2-positive advanced gastric cancer patients.

Achieving PFS in Advanced Gastric Cancer With HLX02 Biosimilar, Chemotherapy

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Here are the top 5 biosimilar articles for the week of November 18, 2024. 

The Top 5 Biosimilar Articles for the Week of November 18

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

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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

The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.

Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data 

Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.

Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data

Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results

The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.

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