The Food and Drug Administration on Friday approved a lower-cost version of the world’s top-selling drug, but don’t expect to see it at the pharmacy any time soon.
Biotech giant Amgen (AMGN) won FDA approval for its version of Humira, an anti-inflammatory treatment from AbbVie (ABBV) that brought in $14 billion in revenue last year. Amgen’s injection, called Amjevita, is a biosimilar of Humira, meaning it’s not identical to AbbVie’s product but has proved in clinical trials that it works just as well.
But an ongoing patent dispute looks likely to forestall Amjevita’s launch.
AbbVie is suing Amgen in hopes of preserving Humira’s patent protection to 2022 or beyond. And even if the pair settle quickly out of court, federal law requires biosimilars manufacturers to wait 180 days after FDA approval before marketing their products, meaning Amgen couldn’t sell Amjevita until March 2017 at the earliest.
Amgen’s new product is approved to treat all of the diseases for which Humira is indicated, including rheumatoid arthritis, psoriatic arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.
The approval marks the fourth time the FDA has given the green light to a biosimilar. Such treatments are expected to cost as much as 30 percent less than their brand-name competitors, and their use could save the US healthcare system about $44 billion over the next decade, according to a report from the RAND Corporation.
But the makers of biosimilars face an uphill battle, as they must convince insurers, physicians, and pharmacies to switch patients from expensive branded treatments. Many companies are running clinical studies to establish biosimilars as interchangeable with the high-cost therapies they mimic, hoping to encourage switching and shake up the market.