Today, the FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated for the treatment of most of the same conditions as its reference product: Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis (in adult patients), rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis. (Remicade®…
As we previously reported, Janssen and Samsung Bioepis jointly filed a stipulation of voluntary dismissal requesting that the District of New Jersey dismiss with prejudice Janssen’s patent infringement claims against Samsung Bioepis based on Samsung Bioepis’s filing of its aBLA for Renflexis® (infliximab-abda). Samsung Bioepis launched Renflexis®, a biosimilar of Remicade®, in…
Below is our fall 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, Summer 2017).
As we previously reported, the United States District Court for the District of Massachusetts denied Celltrion’s motion to dismiss for lack of standing in the Janssen v. Celltrion case. On November 14, 2017, Celltrion filed a motion to certify the court’s order for interlocutory review by the Federal Circuit. In…
On November 14, 2017, Theradiag, a French company specializing in in vitro diagnostics, announced that it had entered into a partnership agreement with Biogen to provide LISA TRACKER kits for monitoring Flixabi®, Biogen’s infliximab biosimilar that is marketed in Europe. Theradiag’s LISA TRACKER kits allow clinicians to monitor trough plasma…
On May 17, 2017, Janssen sued Samsung Bioepis in the District of New Jersey for patent infringement under the BPCIA based on Samsung Bioepis’s filing of its aBLA for Renflexis® (infliximab-abda), a biosimilar of Remicade® that was approved by FDA a month earlier and subsequently launched in July 2017. Janssen’s…
Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies. Johnson & Johnson reported that Remicade (infliximab) sales declined more than 1% in the U.S. and more than 8% worldwide year-over-year. During its earnings call, company executives explained that two-thirds of the decline in sales in Europe…
The United States District Court for the District of Massachusetts has denied Celltrion’s motion to dismiss the action for lack of standing. As we previously reported, Celltrion argued that certain co-owners of the ’083 patent-in-suit were not parties to the action when Janssen filed its 2015 complaint, and that Janssen’s attempts to…
Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of a Phase 3 study of Inflectra demonstrated that “switching patients with Crohn’s disease (CD) to Inflectra from Remicade® (infliximab) led…
A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in patients with moderate to severe rheumatoid arthritis. This study was an extension of a multinational, multi-center phase III study of SB2, which had reported results…