The company's vice president and general manager of U.S. business operations explains how Amgen is going to deliver on its ...

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...

The US Food and Drug Administration (FDA) has approved Celltrion’s biosimilars referencing Amgen’s bone disease therapy ...

On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of ...

Four biosimilars for Stelara have launched in the United States this year following legal settlements with the reference ...

South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt ...

It has been 10 years since the first biosimilar was approved by the FDA. The grades on how the market for biosimilars has ...

Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a ...

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion's blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The biotech has ...

Teva Pharmaceutical (NYSE:TEVA) and Alvotech (NASDAQ:ALVO) have launched their biosimilar targeting Johnson & Johnson’s (NYSE:JNJ) blockbuster arthritis therapy Stelara (ustekinumab) in the U.S. weeks ...

have launched their biosimilar targeting Johnson & Johnson’s (NYSE:JNJ) blockbuster arthritis therapy Stelara (ustekinumab) in the U.S. weeks after Amgen (NASDAQ:AMGN) became the first to launch ...