With patent losses on the horizon, Amgen refocuses its business strategy
The company's vice president and general manager of U.S. business operations explains how Amgen is going to deliver on its ...
JD Supra8h
Amgen and Fresenius Settle Denosumab BPCIA Case
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 ...
PMLive1d
FDA approves Celltrion’s denosumab biosimilars Stoboclo and Osenvelt
The US Food and Drug Administration (FDA) has approved Celltrion’s biosimilars referencing Amgen’s bone disease therapy ...
Healio7d
Two new denosumab biosimilars earn FDA approval
The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...
Healio7d
First four Stelara biosimilars launch in US; ‘white labeling’ threatens market ‘vibrancy’
Four biosimilars for Stelara have launched in the United States this year following legal settlements with the reference ...
Managed Healthcare Executive6d
The Biosimilars Report Card
It has been 10 years since the first biosimilar was approved by the FDA. The grades on how the market for biosimilars has ...
Fierce Biotech14h
Coherus to lose 30% of staff as part of Udenyca sale to Accord
Coherus BioSciences will see its workforce shrink once again as the result of the recently agreed sale of its Neulasta ...
The Pharma Letter7d
FDA nod for two Celltrion denosumab biosimilars
South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt ...
PharmExec7d
FDA Approves Celltrion’s Biosimilars Stoboclo and Osenvelt
Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a ...
Drug Store News6d
Celltrion receives FDA nod for Prolia, Xgeva biosimilars
Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt ...
Teva/Alvotech follow Amgen in launching biosimilar for J&J’s Stelara
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 ...