With the Supreme Court’s pending decision in Sandoz v. Amgen, the interpretation of the patent dance provisions of the BPCIA has been a hot topic here on the blog. For…
With the Supreme Court’s pending decision in Sandoz v. Amgen, the interpretation of the patent dance provisions of the BPCIA has been a hot topic here on the blog. For…
Last week, Apotex filed a Citizen Petition requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta…
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…