Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost ...
At the same time, 90% of U.S. prescriptions are either generics or biosimilars saving the U.S. healthcare system $445 billion in 2023 alone. Despite these achievements, there are important reforms ...
Biosimilars offer affordable medical treatments, but regulatory guidelines need updating to ensure safety, efficacy, and ...
The biosimilar will launch in the United States in June 2025 as part of a global settlement with Amgen, which manufactures the reference product. The higher dosage of denosumab-bnht (Bomyntra ...
A settlement between Amgen and Fresenius Kabi will permit the biosimilar to launch in mid-2025 in the U.S. The FDA has approved two new denosumab biosimilars that are interchangeable with the ...
A Sanofi subsidiary has claimed FDA approval for the first biosimilar of Novo Nordisk's Novolog, an older formulation of the Danish pharma's blockbuster insulin analogue product insulin aspart.
According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1. The FDA has approved two new biosimilars of denosumab for all indications of the ...
The biosimilar approval was based on a comprehensive clinical data package, which included a double-blind, randomized, active-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT04757376 ...
The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for osteoporosis and bone loss in various patient populations. Stoboclo and ...
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