Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808…
Last week the European Commission granted marketing authorization for two biosimilars. First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab biosimilar to AbbVie’s Humira. Authorization was granted for all indications of the reference biologic, including rheumatoid arthritis, plaque psoriasis,…
As we previously reported, the district court granted Sandoz’s motion for summary judgment of non-infringement in the ongoing Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed its opening Federal Circuit appeal brief in May, arguing that the district court made several errors in its…
We previously reported that on December 21, 2017, Genentech filed suit against Sandoz in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. On April 23, 2018, Judge Renee Marie Bumb held an in-person status conference and set forth a preliminary injunction briefing schedule. The Court ordered the motion for preliminary…
Today, in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar, New Jersey District Judge Claire C. Cecchi issued an order that trial will commence on September 11, 2018. (Trial had originally been slated to begin this month.) The Court also ordered the parties to…
Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing authorization of Kanjinti® (ABP 980), Amgen and Allergan’s proposed biosimilar to Herceptin® (trastuzumab). The CHMP opinion recommends…
Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab “is indicated for the treatment of a number of inflammatory diseases including rheumatoid arthritis, plaque psoriasis,…
Stay tuned for an in depth analysis of the arguments.
The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim and pegfilgrastim) have submitted a joint case management statement regarding the two pending cases between the parties: Case No. 3:14-cv-04741-RS (accused product: Zarxio® (filgrsatim-sndz), which Sandoz launched in September, 2015) and Case No. 3:16-cv-02581-RS (accused product: pegfilgrastim (biosimilar to Amgen’s Neulasta®). The parties…
A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July opinion in the case must now be…