On April 1, Sanofi and Regeneron announced positive results in two placebo-controlled Phase 3 studies of dupilumab, a monoclonal antibody under evaluation for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. According to Sanofi’s and Regeneron’s press release: “There are no approved systemic therapies in the U.S….
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…
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…
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…
A jury trial starts Monday, March 7, in the patent case between plaintiff Amgen Inc. and defendants Sanofi and Regeneron over two biologic drugs, Amgen’s Repatha and Sanofi/Regeneron’s Praluent. The case is before Judge Sue Robinson in the District of Delaware. Both products, which are monoclonal antibodies used to treat…