As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered…
In 2017, three indirect-purchaser antitrust class actions were filed against Johnson & Johnson and Janssen Biotech, Inc., alleging that they engaged in anticompetitive conduct relating to the sale and marketing of J&J’s REMICADE (infliximab). The class actions were brought by employee welfare benefit plans, specifically the National Employees Health Plan,…
On July 20, 2021, after nearly four years of litigation, Johnson & Johnson (J&J) and Pfizer have agreed to dismiss all claims asserted in the antitrust suit brought by Pfizer in the Eastern District of Pennsylvania regarding Remicade (infliximab). Remicade is an immunosuppressant that is used to treat Crohn’s disease,…
Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…
Multiple sources are reporting that Celltrion is planning to roll out REMSIMA SC, its subcutaneous infliximab biosimilar of Johnson & Johnson’s autoimmune disease treatment REMICADE, in Europe in the first quarter of 2020, and specifically is targeting a launch in Germany in March, 2020, with launches in the UK and…
We have been covering Pfizer’s antitrust suit against Johnson & Johnson, the manufacturer of REMICADE (infliximab), as well as a related antitrust litigation filed by retailers Walgreen and Kroger Co. and direct and indirect purchasers of Remicade. The cases generally allege that Johnson & Johnson excluded Pfizer’s infliximab biosimilar from the market through anticompetitive bundling and rebate penalties…
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…
As we previously reported, in May 2017, the Competition and Markets Authority (CMA) in the United Kingdom reached a provisional conclusion that Merck Sharp & Dohme Limited (MSD) violated competition law through a discount pricing scheme for Remicade that was likely to restrict biosimilar competition. In March 2019, after considering…
We have covered Pfizer’s antitrust suit against Johnson & Johnson, the manufacturer of Remicade® (infliximab). Pfizer’s suit alleges that Johnson & Johnson excluded Pfizer’s infliximab biosimilar from the market through anticompetitive bundling and rebate penalties for insurers and providers, causing inflated prices. In related litigation, retailers Walgreen and Kroger Co., direct purchasers,…
As we reported here, Pfizer filed an antitrust lawsuit last year 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 since Pfizer introduced its competing biosimilar Inflectra (infliximab-dyyb) in 2016. As…