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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.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
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.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching
December 18th 2024A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
