Samsung Bioepis has announced that its SB8 biosimilar bevacizumab candidate, a proposed US rival to Avastin, has been accepted for review by the FDA.
Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, has announced that its filing for a US biosimilar rival to Genentech’s Avastin (bevacizumab) has been accepted for review by the US Food and Drug Administration.
The biologics license application had been submitted by Samsung Bioepis
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.
An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.
