Amgen and Allergan’s ABP-215 was convincingly presented as equivalent to Roche's bevacizumab (Avastin®). The totality of evidence, according to the FDA staff review documents, supported the 351(k) application by Mylan. The Advisory Committee agreed, voting 16-0 to recommend the biosimilar for approval for use in Herceptin’s indications.
Tag: Amgen
Pegfilgrastim: 0 for 3 on Biosimilars at FDA
The remaining biosimilar version of Neulasta® awaiting its turn at bat in the US is from Mylan/Biocon. Submitted in February of this year, the FDA decision is due October 9, 2017. Pfizer is working on its own version of pegfilgrastim (HSP-130), which is in phase 2 study. Apotex’s Apobiologix unit is still seeking approval of its biosimilar, according to its website. In Europe, 2 pegfilgrastim applications are currently awaiting decisions, but none have been approved to date.
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
Supreme Court to Hear Sandoz v. Amgen Arguments on the 180-Day Notification Period
It seems that the Supreme Court will in fact hear Novartis’ case in an attempt to overturn the 180-day notification period, as part of the “patent dance.” Its biosimilar-making subsidiary (Sandoz) will finally get its day in the nation’s top court in April, with a decision expected sometime in July.