Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue. It reported the following YoY revenue for each…
On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab). According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara. NeuLara…
Celltrion announced last Friday that it will begin Phase I clinical trials of its Prolia (denosumab) biosimilar (CT-P41) in September. Prolia, marketed and sold by Amgen, is a treatment for glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture. Celltrion has said it plans to finish Phase…
Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company. According to Merck, “NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant)…
According to a recent paper in The Lancet, a new phase 3 study shows that CT-P13, Celltrion and Pfizer’s infliximab biosimilar, is non-inferior to the reference biologic, REMICADE, for the treatment of Crohn’s disease. CT-P13 was approved by the European Commission under the trade name Remsima® in September 2013, and…
Below is a summary of recent updates on clinical studies involving bevacizumab and infliximab biosimilars. Bevacizumab: China-based Innovent Biologics announced last week that IBI305, a potential biosimilar to bevacizumab, met pre-defined primary endpoints in two clinical trials against branded bevacizumab. One trial was a phase III clinical trial that compared…
Today, Judge Wolf found in favor of Celltrion, granting its motion for summary judgment of non-infringement of the sole remaining patent-in-suit based on an application of the ensnarement doctrine to Janssen’s infringement theory under the doctrine of equivalents. The Court determined that Celltrion’s infliximab biosimilar does not infringe Janssen’s ’083…
Celltrion Healthcare recently presented research from two studies conducted on its CT-P13 subcutaneous (SC) formulation (biosimilar infliximab) demonstrating positive results for the use of CT-P13 SC in the treatment of active Crohn’s disease and rheumatoid arthritis. According to Celltrion, the data from each study shows the efficacy and safety of…
As we previously reported, in 2017, 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 had engaged in an anticompetitive scheme relating to its Remicade® (infliximab) product. Yesterday, Walgreen and Kroger filed an antitrust lawsuit…
The past week saw further developments in the ongoing patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®. First, on May 4, Janssen and Defendants filed competing motions for summary judgment. Both sets of summary judgment papers are directed to the same issue:…