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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

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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1.0 Credit / Immunology, Pulmonology/Respiratory

Managing Patients With COPD: Evidence-Based Care and Optimizing Value of New and Emerging Targeted Therapies

Celltrion's Omlyclo (omalizumab-igec) is the first omalizumab biosimilar to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor.

FDA Approves First Omalizumab Biosimilar

The FDA approved Avtozma, a tocilizumab biosimilar developed by Celltrion, for the treatment of several rheumatic conditions. It is the third biosimilar to reference Actemra (tocilizumab) to be approved for US patients.

FDA Approves Celltrion's Avtozma as Third Tocilizumab Biosimilar

Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.

Health Canada Approves First Omalizumab Biosimilar

Bevacizumab biosimilars have the potential to expand access and reduce costs without compromising patient outcomes in advanced non–small cell lung cancer (NSCLC)

Retrospective Study Shows Bevacizumab Biosimilar Efficacy in NSCLC

The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.

FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability

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