In a press release, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a first-in-human pharmacokinetics comparison study. GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. It is…
On Friday, April 21, 2017, Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sandoz’s biosimilars rituximab and etanercept in Europe. If approved, rituximab may be used in all indications of MabThera® and etanercept may be used in all indications of Enbrel®. According…
The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer (Hospira’s parent) announced earlier this year that it resubmitted the application in December 2016, following FDA’s rejection…
Today, FDA approved Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®. According to the approved prescribing information, RENFLEXIS® is indicated for the treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis (in adult patients), rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. …
Celltrion announced last week that it has filed for marketing approval of Herzuma (trastuzumab) with Japan’s Ministry of Health, Labor and Welfare. Herzuma is indicated for the treatment of breast and gastric cancers. This would be Celltrion’s second biosimilar to be licensed in Japan, after RemsimaTM (infliximab), and according to The Korea…
On April 14, Amgen filed its reply brief in Sandoz v. Amgen. We have previously reported on Sandoz’s response and reply brief, Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief. As we have previously covered, Sandoz, in response to the cross-petition, argued that when Congress specified that a…
As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of Avastin® (bevacizumab). Today, Amgen filed a letter in response, informing the court that, on March 24, Genentech…
As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal Circuit’s holding in Amgen v. Sandoz. The court granted the motion with leave for Genentech to amend its complaint…
On March 31, Sandoz filed its consolidated response and reply brief in Sandoz v. Amgen. We have previously covered Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief. Amgen’s final reply brief was filed today, and argument is scheduled for April 26, 2017. Sandoz’s brief replied to Amgen’s counterarguments regarding whether an…
Aragen Bioscience, Inc. and Transposagen Biopharmaceuticals, Inc. have filed three petitions for IPR of Kyowa Hakko Kirin Co., Ltd.’s patents: IPR2017-01262 on U.S. Patent 7,425,446; IPR2017-01252 on U.S. Patent 6,946,292; and IPR2017-01254 on U.S. Patent 8,067,232. According to the petitions, the challenged claims are “directed to an isolated mammalian host…