Here are the top 5 biosimilar articles for the week of August 18, 2025.
Number 5: New research shows that denosumab biosimilar SB16 is equivalent to the reference product, Prolia (denosumab), up to 12 months, which carries substantial implications for expanding access to effective treatment for postmenopausal osteoporosis, particularly for those facing financial barriers to originator denosumab therapy.
Number 4: In a recent study, scientists analyzed the quality characteristics of biosimilar monoclonal antibodies and their reference products approved in Japan, assessing multiple product lots to measure variation and lot-to-lot consistency. The findings aimed to inform clinically acceptable quality ranges and strengthen public confidence in biosimilars.
Number 3: The FDA expanded an indication for a tocilizumab biosimilar to include cytokine release syndrome, Kashiv BioSciences and MS Pharma partnered on an omalizumab biosimilar for the Middle East and North Africa, and Lupin teamed with Sandoz on a ranibizumab biosimilar to improve global access to affordable biologics.
Number 2: Biosimilar LY01011 is equivalent to the reference product denosumab for treating bone metastases in solid tumors, demonstrating similar efficacy in reducing bone metabolism biomarkers, comparable safety profiles, and a lack of unexpected adverse reactions.
Number 1: Recent advancements in the biosimilar landscape included the first patent lawsuit regarding a petuzumab biosimilar, a new ustekinumab biosimilar launch, and a new strategy for unbranded biosimilar access.
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