On March 13, 2020, Genentech and Amgen agreed to vacate all pre-trial deadlines and their April 20, 2020 trastuzumab biosimilar jury trial date, due to an issue with a document…
On March 13, 2020, Genentech and Amgen agreed to vacate all pre-trial deadlines and their April 20, 2020 trastuzumab biosimilar jury trial date, due to an issue with a document…
Being ten years in since the enactment of the BPCIA provides us a great opportunity to take a look back at how things have developed in the world of biosimilar…
Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars…
The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute. As we have previously reported, that…
Teva and Celltrion announced yesterday that their HERZUMA (trastuzumab-pkrb) for Injection, a biosimilar to HERCEPTIN, was available in the U.S. The biosimilar has the same indications as…
As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent…
We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to…
Following the oral argument three days ago, the U.S. Court of Appeals for the Federal Circuit today affirmed the lower court’s denial of Genentech’s motion for a preliminary injunction to…
We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation…
We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Yesterday, a Federal…