Samsung Bioepis has reported positive Phase I and Phase III trial results for its SB16 proposed denosumab biosimilar to Prolia.
Samsung Bioepis has published positive Phase I and Phase III trial results for its SB16 proposed biosimilar to Prolia (denosumab) at the annual meeting of the American Society for Bone and Mineral Research.
The randomized, double-blind, three-arm, multi-center, parallel group and single-dose Phase I study for SB16 “demonstrates pharmacokinetic bioequivalence between SB16, EU-sourced denosumab, and
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.
