Samsung Bioepis Co., Ltd., announced that the FDA has accepted its first biosimilar application submitted in the United States. The candidate, SB2, references Janssen’s Remicade® (infliximab), which treats several ailments, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriasis. Remicade® had over ten billion dollars in sales in 2014. As…
The District Court for the District of Massachusetts (Judge Wolf) yesterday decided two pending motions in Janssen v. Celltrion: Plaintiffs’ motion to stay litigation on the ‘471 patent (covering infliximab) pending appeal of the PTAB’s decision invalidating the patent; and Plaintiffs’ motion to amend the protective order to permit them to file…
Remsima, a biosimilar of Remicade (infliximab), was granted a marketing authorization throughout the European Union in 2013. Last week, Merck reported a 30% drop in Remicade first-quarter sales due to “the accelerating impact of biosimilar competition in the company’s marketing territories in Europe.” This will likely be the trend as…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). We also reported on a series of letters concerning Janssen’s request for an expedited trial in view of a possible Celltrion launch in October of 2016. In a letter filed with the court yesterday, Janssen…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). Last week, we also reported that in Janssen v. Celltrion, Janssen filed a letter to the court stating that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…
One week ago, we reported that FDA approved Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab). Today, Janssen filed a letter to the court in Janssen v. Celltrion informing the court that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…
FDA today approved Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab). This is the second biosimilar to be approved by FDA under the new BPCIA regime. For more information, see FDA’s press release on the approval, here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm.
Defendants Celltrion and Hospira in Janssen v. Celltrion have moved for summary judgment that U.S. Patent No. 6,264,471, which covers Remicade (infliximab), is invalid for obviousness-type double patenting. At the District Court status conference earlier this month, Celltrion told the court that it expects FDA approval of its infliximab biosimilar product in…
Yesterday, the FDA’s Advisory Committee overwhelmingly supported approval of Celltrion’s infliximab product, which is a biosimilar for Janssen’s Remicade product. At the District Court status conference in Janssen v. Celltrion, which followed the Advisory Committee vote, Celltrion’s counsel said that Celltrion is expecting FDA approval in about four to eight…
Following FDA support announced last Friday for Celltrion’s proposed Remicade® biosimilar (“CT-P13”), the FDA is holding an Advisory Committee meeting today to discuss Celltrion’s application. On Friday, the FDA said that based on its review of the data, Celltrion’s CT-P13 has been demonstrated to be highly similar to Remicade, notwithstanding…