Attorneys for Amgen and Apotex appeared before the Federal Circuit yesterday to argue about whether the notice of commercial marketing provision, 42 U.S.C. § 262(l)(8)(A), is optional when a biosimilar applicant has provided its application and information to the reference product sponsor (RPS) under paragraph (l)(2)(A). The notice of commercial marketing triggers a…
Since the TPP’s signing by twelve Pacific Rim countries this past February, the agreement has been making its way through the “next phase” of its development—ratification through the signatory countries’ “respective domestic processes.” As we’ve covered previously (see our posts here and here), if enacted, the TPP’s intellectual property provisions…
This is an update on the latest activity before the United States Supreme Court in the ongoing dispute between Amgen and Sandoz regarding Sandoz’s biosimilar application for Zarxio® (filgrastim-sndz). Federal Circuit Proceedings As we previously reported, in May last year, a split Federal Circuit panel held that the patent dance…
In December, AbbVie filed a citizen petition on interchangeability. In its citizen petition, AbbVie argued that before a biosimilar can be designated interchangeable, the FDA should: Require interchangeability be established in each condition of use for which the reference product is licensed, regardless of whether the applicant intends to label…
As we posted yesterday, Amgen has filed a brief in opposition to Sandoz’s petition to the Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz. Amgen’s brief is now available here. The Biosimilars Council also filed a brief, as amicus curiae in support of Sandoz’s petition. Their…
We recently posted about Sandoz’s petition to the Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz here. In their opposition brief filed Monday, Amgen argued that delaying the 180-day notice until after approval would confirm that any requested injunction blocking the biosimilar is factually based….
As we have previously reported, the WHO is considering a proposal to assign Biological Qualifiers (BQs), which are alphabetic codes assigned at random, to help standardize naming of biologics. But not everyone is on board with the WHO’s proposal. The International Generic and Biosimilar medicines Association (IGBA) has recently called…
The Biosimilar User Fee Act (BsUFA) requires FDA to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. On February 24, 2016, the FDA released the Final Results Report of its…
On March 7, 2016, AbbVie and Boehringer Ingelheim announced that they have entered into a global collaboration to develop BI 655066, an anti-IL-23 monoclonal biologic antibody that is in Phase 3 development for psoriasis and also being evaluated as a treatment for Crohn’s disease, psoriatic arthritis and asthma. As part…
On Friday, March 4, 2016, Amgen filed a complaint (available here) seeking a declaratory judgment in the U.S. District Court for the District of New Jersey against Sandoz. The complaint accuses Sandoz of violating BPCIA procedures by failing to participate in certain aspects of the patent dance relating to Sandoz’s…