Stay tuned for an in depth analysis of…
Stay tuned for an in depth analysis of…
The transcript of today’s Supreme Court oral argument in Sandoz v. Amgen has been posted online and is available here. As we covered briefly this morning, the questioning during today’s…
The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five…
As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions: Whether a biosimilar applicant is required by 42…
The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s…
Today, FDA approved Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®. According to the approved prescribing information, RENFLEXIS® is…
On April 14, Amgen filed its reply brief in Sandoz v. Amgen. We have previously reported on Sandoz’s response and reply brief, Amgen’s consolidated opening and responsive brief and Sandoz’s…
We have previously reported on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint. In its letter, Genentech…
As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s…
As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory…