Top of the morning to you, and a fine one it is, despite the dreary gray skies hovering over the Pharmalot campus. We are doing our best to maintain sunny spirits, though, because once again, we recall some helpful wisdom from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” Words to live by, yes? To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Mexican cinnamon, for those tracking our habits. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …
Amneal Pharmaceuticals sued Colorado in an effort to block a state law requiring it to provide free generic EpiPens to pharmacies, Reuters reports. In a complaint filed in a U.S. District Court in Denver, Amneal argued that the law, which was passed last year and took effect in January, was an illegal taking of its property under the 5th Amendment of the U.S. Constitution. The law aims to lower the often high costs of auto-injectors like Viatris’ EpiPen, handheld devices that treat life-threatening severe allergic reactions by automatically injecting a dose of the drug epinephrine. It requires all health insurance plans that cover auto-injectors to provide them at a cost of no more than $60 for a two-pack, a requirement that Amneal is not challenging. The law also requires pharmacies to provide the injectors with the same $60 price cap to people whose insurance does not cover them, and manufacturers in turn to provide the pharmacies with a free replacement or reimbursement for each injector sold under that requirement.
A U.S. judge ruled that Regeneron Pharmaceuticals cannot immediately block U.S. sales of a proposed copy of its blockbuster eye-care drug Eylea, STAT notes. Regeneron has accused Amgen of infringing dozens of patents with a biosimilar version of Eylea called Pavblu. U.S. District Judge Thomas Kleeh rejected Regeneron’s request for a preliminary injunction against Amgen as it pursues the patent lawsuit. Eylea earned Regeneron $5.89 billion in U.S. sales in 2023. Regeneron has sued several other competitors over their proposed Eylea biosimilars, and brought its lawsuit against Amgen in January. The ruling was a surprise, because the same judge had previously granted Regeneron’s request for injunctions against other drugmakers seeking to launch Eylea biosimilars. The U.S. Food and Drug Administration approved Amgen’s biosimilar of Eylea last month. Regeneron responded by filing a notice indicating it would appeal the ruling.
