Drugs

Union Sues AbbVie Over Humira ‘Monopoly’

UFCW Local 1500 Welfare Fund, that provides health and welfare benefits to some 23,000 grocery workers in New York State, is suing AbbVie in an Illinois federal court alleging that it colluded to divide the market for its Humira between the U.S. and Europe and used a “patent thicket” to illegally maintain a monopoly on the drug. The class action antitrust suit says the welfare fund “paid artificially inflated prices for Humira and [was] deprived of the benefits of earlier and more robust competition from less-expensive biosimilar versions of Humira as a result of defendants’ wrongful conduct.”

The action seeks damages and injunctive relief for individuals who purchased Humira and for entities that provided reimbursement for some or all of the purchase price in the U.S. since 1/2017, the date the union says a biosimilar should have been available in the U.S. due to patent expiration.

The union says Humira, a biologic, is the best-selling prescription medication in the world with 2018 global sales reaching nearly $20 billion. The per-patient cost doubled from $19,000 per year in 2012 to more than $38,000 in 2018 after rebates, it says. The list price, absent rebates, can now reach $50,000 per year per patient.

The suit claims that AbbVie used its patents to enter into illegal market division agreements with seven other drug companies in a concerted effort to delay biosimilar entry in the U.S. until at least 2023, while allowing biosimilar entry in Europe years earlier.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome