As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s…
As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s…
Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta…
As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed…
A Stipulation and Scheduling Order for Trial (Order) entered on May 19, 2017 in the Amgen v. Sandoz litigation rescheduled trial for March 26, 2018 (from December 18, 2017), and…
The PTAB has issued a Final Written Decision in IPR2016-00172, filed by Coherus, finding Abbvie’s U.S. Patent 8,889,135 unpatentable as obvious over the prior art. The ‘135 patent is…
Last week, Hospira filed a motion for summary judgment of non-infringement asserting that “all of Hospira’s accused erythropoietin drug substance batches are protected by the safe…
Amgen has filed a BPCIA suit in the District of Delaware against Coherus Biosciences, Inc., alleging infringement of U.S. Patent No. 8,273,707—a patent “directed to a process for purifying…
To view our full FDA Approvals tracking table, click here. Adalimumab+ HUMIRA #1 Biosimilar: AMJEVITA (adalimumab-atto) Applicant: Amgen BLA Approval: Sept. 23, 2016 US Launch: Jan, 31, 2023 Related…
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…