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February 17, 2024
Article
Cyltezo (adalimumab-adbm) was the first adalimumab biosimilar—and second biosimilar overall—to receive an interchangeability designation from the FDA.
February 10, 2024
Article
The authors of a meta-analysis assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.
February 03, 2024
Article
The PERFUSE study in France on biosimilar adalimumab SB5 for inflammatory bowel disease reveals high satisfaction overall, but significant variations in training and survey response rates across sites suggest a potential lack of support during treatment switches.
January 20, 2024
Article
Authors of a review of available postapproval pharmacovigilance data assessing 8 Sandoz biosimilars concluded that these biosimilars “can be used as safely as their respective reference biologics.”
January 13, 2024
Article
The proposed bevacizumab biosimilar BAT1706 (Bio-Thera Solutions) demonstrated equivalence to the reference product (Avastin) in a phase 3 comparative efficacy trial in patients with advanced nonsquamous non–small cell lung cancer (NSCLC).
January 02, 2024
Article
The regulatory structure of biosimilar development can be safely streamlined and made more efficient and less costly, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.
December 16, 2023
Article
The biosimilar Enoxa (enoxaparin), marketed in Tunisia, demonstrated equivalence in preventing subclinical postoperative thrombotic events in patients with digestive cancers to Sanofi’s Lovenox, in a randomized controlled trial.
December 09, 2023
Article
A review article discussed the characteristics of the available adalimumab biosimilars to help clinicians navigate the various treatment options with their patients.
December 02, 2023
Article
A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
November 25, 2023
Article
A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.