On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN. The product will be marketed under the…
On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN. The product will be marketed under the…
On April 14, 2022, the U.S. Court of Appeals for the Federal Circuit reversed the PTAB’s determination in IPR2016-01542 that claims of Amgen’s U.S. Patent No. 8,952,138 are obvious. The…
On March 19, 2022, the parties in the Amgen Inc. v. Hospira Inc. (D. Del., No. 20-201) NEULASTA®/pegfilgrastim litigation submitted a stipulation to dismiss all claims and counterclaims in the…
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting…
In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars. Amgen announced that patients are currently being…
On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in…
On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from…
As we previously reported, Judge Connolly of the District of Delaware stayed the dispute between Amgen and Hospira last month, pending a determination on whether the Court should entertain summary…
…16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s…