Generic drugs currently account for 88% of all U.S. prescriptions, yielding 10-year cost savings in excess of $1.5 trillion. There is some optimism that biosimilars will offer a similar low-cost therapeutic alternative to branded biologics. However, the Journal of the American Medical Association (JAMA) has recently published an article discussing…
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. …
Lanka Business News is reporting that Celltrion and George Steuart Health have teamed up to launch Remsima (infliximab) in Sri Lanka. According to the article, this is the first biosimilar available in Sri Lanka. The article states that the launch took place at the Cinnamon Grand Colombo in Sri Lanka, and…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also previously reported, Janssen filed its opening appeal brief on January 26, 2017. On March 7, 2017, Celltrion filed its response brief. Celltrion argues that…
The court has issued a memorandum and order reflecting the guidance it provided during the Feb. 23 and 24, 2017 hearing concerning the standards for determining damages in the litigation. The guidance is here. Stay tuned to Big Molecule Watch for more updates.
As we previously reported regarding Janssen v. Celltrion, after the district court postponed trial and heard oral argument on the damages issues related to Celltrion’s challenge to Janssen’s standing, the Court set a deadline for Celltrion to file a motion to dismiss on that basis. On Friday, February 22, 2017, Celltrion filed its Motion…
As we reported last November, the NOR-SWITCH Phase IV study concluded that patients could be safely and effectively switched from originator infliximab (Remicade®) to Celltrion’s biosimilar product CT-P13 (Remsima®). On February 17, Celltrion Healthcare and Pfizer released primary outcome data at the 12th Congress of the European Crohn’s and Colitis…
Below is our midwinter 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).
As we previously reported, a jury trial in the ongoing infliximab biosimilar litigation, Janssen v. Celltrion (D. Mass., J. Wolf), was scheduled to begin on February 13, 2017. The district court, however, recently cancelled the originally scheduled trial date and is now scheduled to hold a hearing to address damages…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, directed to monoclonal antibodies including infliximab or cA2 antibody, is invalid. On January 26, 2017, pursuant to a 30-day extension, Janssen filed its opening appeal brief, in which Janssen challenged the two district…