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…
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…
Amgen, Hoffmann-La Roche and Immunex have filed a complaint in the District of New Jersey against Sandoz alleging patent infringement of the plaintiffs’ etanercept (ENBREL) patents under the BPCIA provisions of 35 U.S.C. § 271. The plaintiffs are also seeking declaratory judgment of patent infringement on the grounds that Sandoz…
Last week, Judge Richard Andrews in the District of Delaware heard argument in Amgen v. Hospira on Hospira’s motion to dismiss Amgen’s action over notice provisions in the Biologics Price Competition and Innovation Act (“BPCIA”). Hospira, now owned by Pfizer Inc., argued that Amgen cannot seek an injunction to enforce…