Recently in pharma news, in a 9 – 0 ruling, the U.S. Supreme Court overturned a lower court’s decision that prevented Novartis from selling its biosimilar version of Neupogen, a drug made by California-based Amgen Inc. Prior to the ruling, biosimilar drugs (also referred to as “copycat” versions of other drugs) could not be put on the market until six months after approval by the FDA.
Novartis’ Sandoz division was in dispute with rival, Amgen, over Sandoz’s generic biologic alternative to Amgen’s Neupogen, a nearly identical drug used in cancer patients to stimulate the growth of white blood cells for fighting infection. Sandoz’s drug, Zarxio, is said to sell for approximately 15% less than Neupogen, according to an article at U.S. News.
Obamacare, or the 2010 ACA, created an expedited path to allow biosimilars to gain regulatory approval while at the same time attempting to respect brand-name pharmaceutical manufacturers’ patent rights. The dispute between Novartis’ Sandoz division and Amgen involves a section of the Affordable Care Act – namely that, even after 12 years of exclusivity had passed (provided under the law for drug makers), Amgen was given another six months by the U.S. Court of Appeals in a 2015 ruling. The additional six months stems from the fact that biosimilar manufacturers must face a six month waiting period, after being approved by the FDA, before they can sell their product.
Following the unanimous Supreme Court Decision, Justice Clarence Thomas said the 2010 law does not require an additional six-month wait for companies producing biosimilars, after gaining FDA approval.
Great news for generic drug maker Sandoz; however, on the flip side of the coin, not such great news for original drugmakers who, over a six-month period of time, could add additional sales in the millions or even billions of dollars without the added competition.
REA JET is a leading global supplier of inkjet printing, laser marking, and other coding and marking solutions for the pharmaceutical and other industries. For all of your industrial printing needs, trust REA JET to provide quality, cost-effective solutions.