IBS-C Treatment Zelnorm Withdrawn From the Market Again
The decision to remove Zelnorm from the market was strictly a business decision.
The decision to remove Zelnorm from the market was strictly a business decision.
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
Familial adenomatous polyposis is caused by abnormalities in the APC gene.
The phase 3 ELEVATE 12 trial evaluated the efficacy and safety of etrasimod 2mg once daily vs placebo in 354 patients.
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
The PAS is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis.
Guidelines address diagnosis and management, use of diagnostic colonoscopy in complicated disease, and interventions to prevent recurrence
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
PillCam SB3 @HOME offers a telehealth option for direct visualization and monitoring of the small intestine.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.