Over the past couple of quarters, AbbVie investors have bristled at the sight of top-seller Humira missing expectations outside the U.S. In Q4, though, the world's best seller rebounded outside its home country, topping predictions to help sales and profits stay generally in line despite a rough U.S. quarter for hep C drug Viekira Pak.
On Monday, Amgen said the FDA had accepted its application for its biosimilar of AbbVie's Humira, so-called ABP 501--but earlier this month, the U.S. Patent and Trademark Office shut down its challenge to Humira's patents.
The U.K.'s cost effectiveness gatekeepers are giving their final blessing to a slew of rheumatoid arthritis biologics--but only for patients with advanced forms of the disease. And drugmakers aren't exactly happy about it.
Amgen has hit a potential snag in its quest to bring a biosimilar of AbbVie cash cow Humira to market. Thursday, the U.S. Patent and Trademark Office declined to review a pair of formulation patents on the arthritis drug, determining that "based on the petition and the accompanying evidence … Amgen has not shown a reasonable likelihood of prevailing on any of its challenges," Reuters reports.
Partners Baxalta and Momenta Pharmaceuticals, among the many contenders looking to challenge the world's top-selling drug, posted positive data for their take on AbbVie's Humira with hopes of launching a competitor in 2018.
Plenty of drugmakers are working on biosimilar copies of AbbVie's Humira, gunning for a piece of the med's world-leading sales. But Amgen believes it's ahead of the pack in the U.S., and on Wednesday, it got one step closer to taking its shot.
Amgen's knockoff of AbbVie's top-selling Humira measured up to its reference product in a Phase III trial, clearing the way for the Big Biotech as it waits for the blockbuster injection to lose patent protection next year.
Humira continued to bring in more than half of AbbVie's revenues, exceeding analysts' expectations and propelling the drugmaker to an earnings beat. But one of the company's hopefuls, hep C med Viekira Pak, missed in Q3, potentially throwing a wrench into AbbVie's plans to reap more from new meds.
A new pill from Eli Lilly and Incyte beat AbbVie's injectable Humira, the world's top-selling drug, in a Phase III rheumatoid arthritis trial, setting the stage for an FDA submission.
As the world's best-selling drug, AbbVie's Humira has a biosimilar target painted on its back--and Baxalta is the latest to take aim.