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Pharma Groups Denied Restraining Order in Nevada Drug Pricing Lawsuit
Judge James C. Mahan of the US District Court denied the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO)’s motion for a temporary restraining order that would force Nevada to “cease and desist all action implementing or enforcing” contested sections of Nevada’s Senate Bill 539.
Judge James C. Mahan of the US District Court denied the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO)’s motion for a temporary restraining order that would force Nevada to “cease and desist all action implementing or enforcing” contested sections of Nevada’s Senate Bill (SB) 539.
SB 539, signed into law by Republican Governor Brian Sandoval, requires drug makers to annually disclose list prices for insulins, profits made, and discounts provided to pharmacy benefit managers. It also requires drug makers to explain spikes in insulin pricing. Trade groups PhRMA and BIO called the drug “unprecedented” and “unconstitutional.”
In his decision, Mahan indicated that the court could rule a temporary restraining order only if the moving party showed that immediate and irreparable loss or damage would result before the opposing party’s motion for a preliminary injunction could be heard. He called such a restraining order an “extraordinary remedy” that would not be granted without the plaintiff’s demonstrating the possibility of irreparable. Mahan said that PhRMA and BIO had not shown that they would suffer such damage, in part because the first disclosures from industry concerning drug pricing will not be due until July of 2018.
Now that the motion for the restraining order has been denied, the state will have until September 27, 2017 to file its reply to PhRMA and BIO’s motion for preliminary injunction.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
