As we reported yesterday in the Amgen v. Hospira litigation, Amgen filed a motion for leave to file an amended brief in support of its Motion for a Preliminary Injunction,…
As we reported yesterday in the Amgen v. Hospira litigation, Amgen filed a motion for leave to file an amended brief in support of its Motion for a Preliminary Injunction,…
As we previously reported in the Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary…
…28, 2017, at 12:00 PM EST, Goodwin will host a webinar discussing the Supreme Court’s Decision in Sandoz v. Amgen. On June 12, the Supreme Court decided Sandoz v. Amgen,…
Today, Boehringer Ingelheim announced the 24-week results from the Phase III VOLTAIRE®-RA study, comparing the adalimumab biosimilar candidate BI 695501 to Abbvie’s Humira® in patients with…
The PTAB has issued Final Written Decisions in IPRs filed by Coherus against two of Abbvie’s patents, IPR2016-00188 (U.S. Patent No. 9,017,680) and IPR2016-00189 (U.S. Patent No. 9.073,987),…
We previously reported on the oral argument in Sandoz v. Amgen. Today Justice Thomas delivered the opinion for a unanimous U.S. Supreme Court in Sandoz v. Amgen. Briefly, the Supreme…
The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications. During…
Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates….
As we previously posted, Amgen seeks discovery from AbbVie regarding its “patent dance” exchanges with other adalimumab biosimilar applicants under the BPCIA. Last Friday, AbbVie filed its…
On Friday, in the ongoing Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary…