Three other biosimilar manufacturers have already filed for approval in the US: Amgen/Allergan and Celltrion/Teva (separately) in July 2017; Mylan/Biocon in November 2016. Roche settled its patent claims against Mylan in March 2017, which provides Mylan with a license to sell its biosimilar version of Herceptin® should it gain FDA approval next year.
Tag: patent
Can Biosimilars Be Protected By Patent?
“Are biosimilars patentable?” Sounds like a simple question, right? Well, the answer may not be straightforward, and relate to another question: "Exactly how different are they?"
Frustration Mounts as Sandoz’s Etanercept Biosimilar Launch Delayed into 2018
Call it irritation, exasperation, or frustration, but biosimilar manufacturers and payers alike are feeling it, as the fight over drug patents has barred the way to approval for yet another biosimilar for a costly biologic. In this case, Sandoz’s Erelzi™, which was approved by the Food and Drug Administration on August 30, 2016, has been … Continue reading Frustration Mounts as Sandoz’s Etanercept Biosimilar Launch Delayed into 2018