On July 16, 2025, Bio-Thera Solutions and Accord announced the FDA acceptance of their aBLA for BAT2506, a proposed biosimilar of Janssen / Johnson & Johnson’s Simponi® (golimumab). ...more
On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI®...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
On July 24, 2024, Bio-Thera Solutions announced the FDA acceptance of its aBLA for BAT2206 (ustekinumab), a proposed biosimilar of Janssen and Johnson & Johnson’s Stelara® (ustekinumab), with a request for interchangeability....more
I read the Lewandowski v. Johnson & Johnson class action complaint and couldn’t help but wonder – are plans and participants doomed, or can employers take proactive steps to satisfy their fiduciary duties and potentially...more
Under the Consolidated Appropriations Act of 2021 (“CAA”), employer-sponsored group health plans, including medical-only plans, must submit information about their prescription drugs and health care spending. This submission...more
Many medical benefit plan fiduciaries contract with pharmacy benefit managers (“PBMs”) to administer the prescription drug portion of their health plans, placing the PBM in charge of day-to-day management of the programs....more
The first complaint was filed in what is expected to be a wave of litigation alleging breach of fiduciary duty in selecting and monitoring welfare plan vendors. While the facts of this particular case may make it somewhat...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
A novel proposed class action lawsuit was filed against Johnson & Johnson (J&J) earlier this month by a current employee for mismanagement of prescription drug prices. The lawsuit alleges, among other things, that J&J...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
States, counties, and cities within weeks could start to receive desperately needed money to battle the deadly opioid abuse and overdose crisis as part of a newly finalized, $26 billion settlement with the largest...more
The past year saw several attempts to apply new applications of the public nuisance doctrine to the opioid crisis. While in the past, public nuisance claims typically sought recovery for damages in connection with land use in...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 November 9, 2021, the Oklahoma Supreme Court set aside a $465 million verdict against Johnson & Johnson (J&J) in State ex rel. Hunter v. Johnson & Johnson, 2021 OK 54. In 2017, the State of Oklahoma sued three opioid...more
On November 9, 2021, the Oklahoma Supreme Court in State ex rel. Hunter v. Johnson & Johnson, No. 118474, 2021 WL 5191372 (Okla., Nov. 9, 2021), overturned a $465 million verdict against opioid manufacturer, Johnson & Johnson...more
Public nuisance claims have long been understood to rest on “an unreasonable interference with a right common to the general public.” Typically, litigation sought recovery for damages in connection with (among other...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
Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits - in settling claims over distributors...more
Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: J&J Settles Opioid-Related New York Suit for...more
Over the last two months, McKinsey & Company — one of the world’s largest consulting firms — resolved matters with all 56 state attorneys general regarding investigations into its role in providing marketing and consulting...more
Walmart and Johnson and Johnson, two of America’s corporate titans, each acted in ways that helped to fuel the opioid crisis that federal experts estimate claims 128 Americans’ lives each day, news media investigations show....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
Last October, I reported on the $8 billion punitive verdict returned by a Philadelphia jury against Johnson & Johnson in a case alleging that the company had failed to warn that its antipsychotic drug Risperdal could cause...more