The Food and Drug Administration on Friday approved a version of low cost drug selling in the world, but do not expect to see him at the pharmacy in the short term.
biotechnology giant Amgen obtained approval from the FDA for your version of Humira, an anti-inflammatory treatment Abbvie brought in $ 14 billion in revenue last year. Amgen injection, called Amjevita, is a biosimilar of Humira, which means it is not identical to the product of Abbvie but has been shown in clinical trials that works just as well.
But a patent dispute in progress looks like it will prevent the release of Amjevita.
The article continues after the announcement
Abbvie is suing Amgen hoping to preserve the protection of patents Humira and 2022 or beyond. And even if the pair quickly resolved out of court, federal law requires that biosimilar manufacturers to wait 180 days after FDA approval before marketing their products, which means Amgen could not sell Amjevita until March 2017 at the earliest.
Amgen new product is approved for the treatment of all diseases for which Humira is indicated, including rheumatoid arthritis, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis.
Approval is the fourth time that the FDA has given the green light to a biosimilar. It is expected that such treatments cost as much as 30 percent less than its competitors brand, and its use could save the health system in the United States about $ 44 billion over the next decade, according to one RAND Corporation report .
However, manufacturers of biosimilars face an uphill battle because they must convince insurers, doctors and pharmacies to switch patients from expensive branded treatments. Many companies are running clinical trials to establish biosimilars as interchangeable with therapies that mimic high cost, hoping to encourage the substitution and shake the market.