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. …
More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey, Arizona, Missouri, Oregon and Pennsylvania. On February 22, 2017, H 203 was signed into law in Montana. On March 10, 2017 HF 305 was signed into…
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…