Yesterday, Johnson & Johnson (J&J) released its Q2 2018 financials and held an earnings call with analysts. J&J reported Remicade® sales in Q2 2018 of $918 million in the U.S. and $1.320 billion worldwide, which is a 13.7% decline over the sales J&J reported for the same quarter last year…
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…
Last week, Johnson & Johnson held its earnings call for the fourth quarter of 2017. During the call, company representatives discussed an 8% decline in U.S. sales for Remicade as Johnson & Johnson “continued to compete in the phase of biosimilar entries.” As we previously reported, there are two biosimilars…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017: 1. Compared to three approvals in 2016, the FDA approved five biosimilar products in 2017: Renflexis® (infliximab-abda) Cyltezo® (adalimumab-adbm) Mvasi® (bevacizumab-awwb) Ogivri® (trastuzumab-dkst) Ixifi® (infliximab-qbtx) In a press release regarding the approval for…
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…
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…
On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their reference products distinguishable, nonproprietary names. Today, the FDA published a follow up letter responding to the pending citizen…
The European Crohn’s and Colitis Organisation (“ECCO”) released a statement last week supporting the switch from the reference infliximab to biosimilar infliximab in patients with inflammatory bowel disease (“IBD”). ECCO’s new position is particularly significant, given its earlier position taking a cautious approach to biosimilars and suggesting that “rigorous testing [of biosimilars]…
A study conducted by the Norwegian government compared Johnson & Johnson’s Remicade (infliximab) to Celltrion’s approved biosimilar Remsima. The “NOR-SWITCH” study, which cost $2.5 million, was a 52-week Phase IV study that began in October 2014. The results were presented on Tuesday during the United European Gastroenterology Week in Vienna, Austria. The…
During the European Academy of Dermatology and Venereology Congress in Vienna, Johnson & Johnson presented data on their experimental psoriasis drug, guselkumab. Guselkumab targets a protein, interleukin-23, which is specifically involved with the skin’s immune responses. Guselkumab cleared or nearly cleared the skin of 81% of patients during a final-stage…