Four biosimilars for Stelara have launched in the United States this year following legal settlements with the reference product manufacturer, Janssen Pharmaceuticals, which set timelines for ...

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 ...

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 ...

Several phase II–III studies have shown that the EGFR-targeting monoclonal antibody, cetuximab, offers clinical benefit for patients with SCCHN. Cetuximab monotherapy is active in patients whose ...

South Korea-based Celltrion (Kosdaq: 068270) today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Amgen’s ...

Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more ...

Treatment with Krazati (adagrasib) plus Erbitux (cetuximab) demonstrated meaningful efficacy in heavily pretreated patients with KRAS G12C–mutant unresectable or metastatic colorectal cancer, ...

Stelara biosimilars are used to treat certain inflammatory conditions. Shire, Teva settle litigation over ADHD drug Teva announces availability of generic Vibramycin ...

Ustekinumab is a human interleukin-12 and -23 antagonist indicated for multiple chronic inflammatory diseases. A biosimilar is a biological product that is approved based on data demonstrating that ...

The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its ...

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar. February brought policy updates and several biosimilar approvals, ...

The Global Oncology Biosimilars Market is expected to grow at 18.5% CAGR from 2025 to 2032. The latest Research report published by CMI with the title "An Increase in Demand and Opportunities for ...