Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision under the Food and Drug Administration Amendments Act (FDAAA), which was enacted in 2007, that provides the FDA with…
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…
We have previously reported on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint. In its letter, Genentech requested entry of judgment without prejudice, which Amgen argued was unnecessary given the court’s prior order of dismissal without prejudice. This morning,…
The House and Senate Committees released a draft bill on Friday to reauthorize user fee programs for biosimilars, pharmaceuticals, generic drugs, and medical devices from 2018 to 2022. The bill states that the fees authorized by the amendments will be dedicated to, among other things, expediting the review process for…
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 March 29, Senator Al Franken and fifteen co-sponsoring Senate Democrats introduced a bill called the “Improving Access to Affordable Prescription Drugs Act” (S. 771). A companion bill (H. 1776) with the same title was introduced the same day in the House by Representative Schakowsky and four co-sponsoring House Democrats….