Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. (“Janssen”) and Johnson & Johnson’s motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. (“Samsung”)...more
On March 3, 2025, Fresenius Kabi and Formycon announced the launch of Otulfi™ (ustekinumab-aauz), a provisionally interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), subject to the...more
On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Celltrion previously reached a settlement agreement...more
In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson, the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal strategy against biosimilar competitors, including...more
On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more
On December 7, 2023, a group of health insurers and health insurance administrators filed a class action complaint against Johnson & Johnson and Janssen Biotech, Inc. (collectively “J&J”) in the Eastern District of Virginia...more
It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to...more
On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
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...more
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,...more
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...more
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%...more
Walgreens and Kroger have filed an antitrust action in the United States District Court for the Eastern District of Pennsylvania accusing Johnson & Johnson (J&J) of engaging in anticompetitive conduct designed to stymie the...more
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...more
As we previously reported, on September 20, 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 has engaged in an...more
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...more
Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more
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...more
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...more
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...more
The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more