Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
Last week, AbbVie held its third quarter 2022 earnings conference call, which included considerable discussion of forthcoming competition with biosimilars to HUMIRA (adalimumab) in 2023....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
An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two...more
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah...more
On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the first adalimumab biosimilar...more
Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets....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
Only three months after AbbVie obtained a retrial of a case in which a jury had imposed $150 million in punitive damages without awarding any compensatory damages, a new jury awarded the same plaintiff $200,000 in...more
It has been reported that manufacturer AbbVie will increase the price of Humira® (adalimumab) by 9.7% in 2018. According to Wells Fargo analyst David Maris, this price increase could add an additional $1.2 billion to the U.S....more
Today, AbbVie announced that the F.D.A. approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis....more
An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on July 12, 2016. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s...more
Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more