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 16, 2025, EmblemHealth, Inc. (“Emblem”) filed a class action suit in the District Court for the District of Massachusetts against Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd....more
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...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
As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at...more
The Seventh Circuit recently confirmed that Actavis is the appropriate framework to assess biosimilar patent settlements, despite the differences in the regulatory structure—the first appellate court ruling on this issue. In...more
The Seventh Circuit issued this week a long-awaited opinion in the HUMIRA antitrust litigation, UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402. The appeal is from the Northern District of Illinois’s...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
After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more
A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more
Last month, Judge Manish Shah of the United States District Court of the Northern District of Illinois dismissed an antitrust complaint brought by indirect purchasers of AbbVie’s blockbuster rheumatoid arthritis drug,...more
On June 10th, Judge Manish S. Shah, U.S. District Court Judge for the Northern District of Illinois, dismissed (without prejudice) a class action lawsuit against AbbVie and AbbVie Biotechnology Ltd. by consumer groups, drug...more
In a recent decision in In Re Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873, Judge Shah of the Northern District of Illinois dismissed a consolidated class action complaint filed by U.S. purchasers of AbbVie Inc.’s...more
We have previously reported on the class action suit against AbbVie alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the...more
On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive...more
On March 18, 2019, UFCW Local 1500 Welfare Fund, a New-York based grocery union, filed a putative class-action lawsuit against AbbVie and seven adalimumab biosimilar manufacturers alleging misconduct and antitrust violations...more
Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...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
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
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...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
Though politics ruled the headlines in 2016, the year still brought big changes in intellectual property law and its application, most notably in patent subject matter eligibility, inter partes review institution and appeal...more
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more