Last week, Mylan announced on its quarterly earnings call that the U.S. FDA has accepted the company’s aBLA for a biosimilar of AVASTIN (bevacizumab), which is now under review with…
Last week, Mylan announced on its quarterly earnings call that the U.S. FDA has accepted the company’s aBLA for a biosimilar of AVASTIN (bevacizumab), which is now under review with…
Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration…
On Feb. 13, 2020, the European Medicines Agency (EMA) granted market authorization for Amsparity, Pfizer’s adalimumab biosimilar. Amsparity is approved for use in treating the same set…
As we previously reported, Amgen sued Pfizer and its affiliate Hospira in July 2018 based on Hospira’s submission of an aBLA for a biosimilar of NEULASTA (filgrastim). That same month,…
On February 11, 2020, in the Genentech v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of…
On February 11, 2020, Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim). Pegfilgrastim is indicated for decreasing…
Below we provide an update on some recent developments from several biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Immunex Rhode Island, Fed. Cir. Case No. 19-2155 –…
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA…
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir….
Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending…