Last June, we reported that Coherus BioSciences had received a Complete Response Letter (CRL) from the FDA for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim). Later, in August, we reported that Coherus had anticipated resubmitting its BLA in response to the CRL. Today, Coherus announced that it has resubmitted its BLA…
Yesterday, Sandoz announced that the FDA has issued a Complete Response Letter (CRL) regarding its aBLA for its proposed biosimilar of Rituxan® (rituximab). Sandoz states that it “stands behind the evidence that it submitted to the FDA and that, “[w]hile disappointed, Sandoz remains committed to further discussions with FDA in…
As we reported last month, many state legislatures have passed or are considering biosimilar substitution bills. Alaska, Connecticut, New Hampshire, and Vermont are the latest states to join this list. Last week, the Alaska legislature passed SB 32, entitled “Prescriptions for Biological Products,” which allows substitution of “an interchangeable biological…
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…
As we reported earlier this week, the Supreme Court held in SAS Institute Inc. v. Iancu that when the PTAB institutes an IPR, it must decide the patentability of all challenged claims. The U.S. Patent and Trademark Office yesterday issued guidance on the impact of SAS. The guidance explains that going forward: …
We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could begin commercial marketing of its product. In particular, Genentech had sought a judgment that Amgen could not market its product…
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…
AbbVie recently announced positive results for upadacitinib, a small molecule Janus Kinase (JAK) inhibitor, in a phase 3 clinical trial of patients with rheumatoid arthritis (RA). According to AbbVie, upadacitinib met all primary and secondary endpoints in the study, including superiority versus adalimumab, the anti-TNFα antibody that Abbvie markets as…
Last week, Japan-based Nichi-Iko Pharmaceutical Co. announced the completion of a biologics production facility in Osong, South Korea by its Korean affiliate Aprogen Biologics “[t]o provide a stable supply of premium quality biosimilars to market in the USA as well as Japan.” The facility will reportedly use a perfusion system…
This morning, the United States Supreme Court issued two key decisions concerning the fundamental authority of the United States Patent and Trademark Office (USPTO) to institute inter partes review (IPR) proceedings. First, in Oil State Energy Services, LLC v. Greene’s Energy Group, LLC, the Court held in a seven to two…