Originally approved by the FDA in September 2023, Biogen's Tofidence became the first tocilizumab biosimilar available in the ...

CVS Caremark, Express Scripts and Optum Rx — the three largest pharmacy benefit managers in the U.S. — each excluded more ...

Teva Pharmaceuticals and Alvotech last Friday launched Selarsdi, a biosimilar to Stelara. The Food and Drug Administration has allowed the use of Selarsdi as an "interchangeable" substitute only ...

The US Food and Drug Administration (FDA ... for all indications of the reference product denosumab (Prolia/Xgeva). The biosimilar will launch in the United States in June 2025 as part of a ...

The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These ...

Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis). Omlyclo was approved to treat the same conditions as Xolair. The FDA approved Celltrion’s omalizumab ...

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 ...

Biosimilar competition has a demonstrated record of generating significant systemic savings while still incentivizing continued drug innovation. Adjusted for inflation, the average prices for ...

Dublin, March 19, 2025 (GLOBE NEWSWIRE) -- The "2024 Sales of Therapeutic Antibodies, Proteins, Biosimilars, Gene & Cell Therapy and Therapeutic RNA" report has been added to ResearchAndMarkets ...

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 ...

Researchers have discovered a new antibiotic molecule that targets a broad range of disease-causing bacteria — even strains resistant to commercial drugs ... One sample showed potent ...

FDA commissioner Scott Gottlieb said: “Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs an ...