Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils ...

Steqeyma is indicated for the treatment of plaque psoriasis and psoriatic arthritis in adult and pediatric patients, as well ...

The FDA defines a biosimilar as a biological product that is highly similar to an FDA-approved brand-name biologic drug (known as the reference product) used in the prevention or treatment of disease.

STEQEYMA ®, one of the first-wave biosimilars to STELARA ®, is now available ... STEQEYMA will be priced with a wholesale acquisition cost (WAC) list price at an 85% discount to the current ...

JERSEY CITY, N.J., March 12, 2025 /PRNewswire/ -- Celltrion today announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA&circledR ... STEQEYMA will be priced with ...

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation ...

Biotechnology firm Biocon Ltd on Friday (March 7) said its subsidiary Biocon Biologics Ltd has announced positive results from its phase 3 clinical trial for Yesintek, a biosimilar to ustekinumab ...

On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's (ROG: SIX) anti-IgE monoclonal antibody Xolair (omalizumab). The FDA ...

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 ...

Japanese drugmaker Kyowa Kirin and Swiss generics and biosimilars giant Sandoz have won approval for the partial change of their rituximab biosimilar for the treatment of refractory nephrotic syndrome ...

Celltrion's Omlyclo (omalizumab-igec) is the first omalizumab biosimilar to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the ...

The products are expected to be available in June 2025. The US Food and Drug Administration (FDA) has approved Stoboclo (denosumab-bmwo), a biosimilar to Prolia (denosumab), and Osenvelt ...