Sandoz Biosimilar Strategy For Etanercept: Start Small, But Test Globally
This article was originally published in PharmAsia News
Sandoz has begun a global Phase III trial with its biosimilar version of Amgen's Enbrel (etanercept), targeting psoriasis rather than the more lucrative indication for rheumatoid arthritis, with the aim of winning quicker regulatory approval which can be built on as it gains insights testing the medicine.
You may also be interested in...
Novartis’ Serelaxin Poised For Standard FDA Review
Despite the fact that Novartis’ serelaxin has been granted breakthrough therapy designation from FDA, the heart failure candidate will receive a standard 12-month review, management said during a second quarter sales and earnings call.
The Name Game: Will Innovators’ Latest Battlefront Kill Biosimilars?
Having lost the battle to prevent biosimilars reaching the market at all, innovators are now pushing for them to be stamped with unique international non-proprietary names. That could prove commercially fatal for copycat biologics.
GPhA Battles State Biosimilar Bills; 5 Passed, 10 Rejected
Generic Pharmaceutical Association wants to assure legislation on biologics substitution does not impose more restrictions than required for small molecules; opposes measures pushed by Amgen and Genentech.