Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second…
Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second…
On October 11, 2018, AbbVie and Sandoz announced that they reached a global resolution of all intellectual property-related litigation concerning Sandoz’s Hyrimoz™, a proposed biosimilar of…
As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira,…
Below are some recent updates regarding U.S. regulatory submissions and a launch in connection with biosimilar products: On September 27, 2018, Samsung Bioepis announced that the U.S. FDA…
As we previously reported, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219). According to the petition, the challenged…
We previously reported on discovery disputes in the adalimumab litigation between AbbVie and Boehringer Ingelheim (BI) pending before the District of Delaware. Earlier this month, Judge Lloret…
In a complaint filed yesterday, the State of California sued AbbVie, Inc. based on an alleged kickback scheme in connection with AbbVie’s Humira® (adalimumab). The complaint alleges that AbbVie…
As we have previously reported, a jury in September 2017 issued a $70,000,000 verdict against Hospira based on its drug substance manufacturing activity in 2013-2015 in connection with its…
Genentech recently submitted two opening appellate briefs to the Federal Circuit in connection with its appeals from the Board’s final written decisions in Hospira’s IPRs, IPR2016-01771…
Below we provide updates in three pending litigations. First, in an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening…