As we noted earlier today, this week the Federal Circuit is holding oral argument at various venues in New York City. Two of today’s oral arguments were in biosimilar cases that we have been closely following on this blog. Janssen v. Celltrion The morning began with a panel of Judge…
We previously reported that, according to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar of Roche’s Lucentis® (ranibizumab injection), for the treatment of neovascular age-related macular degeneration. The South Korean Ministry of Food and Drug Safety reportedly approved…
Today, Pfizer filed an antitrust lawsuit against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade® (infliximab) product. The complaint alleges that “[w]hen Pfizer introduced its competing biologic Inflectra (infliximab-dyyb) in 2016, J&J…
This morning, the district court in Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, entered a pretrial scheduling order. The scheduling order calls for, among other things, fact discovery to close on August 30, 2018, expert discovery to close on January 31, 2019, and any dispositive motions…
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017).
As we previously reported last year, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Janssen appealed the district court’s partial final judgment of invalidity of Janssen’s ’471 patent based on a finding of obviousness-type double patenting. The Federal Circuit is treating that appeal as a companion case…
Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. Coherus reported that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and that its total revenue for the first half of 2017 was $1.6 million. In response to a question…
Merck & Co. and Samsung Bioepis announced today the U.S. launch of Renflexis (infliximab), a biosimilar of Janssen’s Remicade. Renflexis was approved on April 21 by the FDA for all eligible indications. Renflexis will be priced at a 35% discount to the current list price of Remicade (i.e., 65% of…
Last week, an article reviewing the literature comparing infliximab biosimilar CT-P13 (Celltrion) with infliximab (Janssen Biotech) for the treatment of rheumatologic diseases was published in Drug Design, Development and Therapy. Noting that many European specialists had reported having only a basic knowledge of biosimilars, the authors sought to critically analyze…
As we previously reported in the dispute brought by Janssen against Hospira and Celltrion regarding infliximab, Defendants filed a motion to dismiss the 2015 and 2016 consolidated actions for lack of standing. In those actions, Janssen asserted infringement of the ‘083 patent (as well as other patents which were later…