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…
On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin alfa) (audio available here). In this dispute, Amgen is seeking to compel production of information concerning Hospira’s manufacturing process, including…
Lanka Business News is reporting that Celltrion and George Steuart Health have teamed up to launch Remsima (infliximab) in Sri Lanka. According to the article, this is the first biosimilar available in Sri Lanka. The article states that the launch took place at the Cinnamon Grand Colombo in Sri Lanka, and…
On April 5, Immunex (a wholly-owned subsidiary of Amgen) filed a complaint against Sanofi and Regeneron related to Sanofi and Regeneron’s Dupixent® (dupilumab) product, which received FDA approval last week. Immunex’s complaint was filed in the District Court for the Central District of California and asserts patent infringement and seeks a declaratory judgment of…