“Skinny labeling” is a practice by which follow-on drug manufacturers seek approval for some but not all indications for which branded drugs are approved.
Medicare saved $1.5 billion between 2015 and 2020 as a result of competition between five biologic drugs and their skinny-label biosimilars.
Recent judicial rulings are threatening these savings for Medicare and the availability of those and other biosimilars through skinny labeling, according to a report published online in JAMA Internal Medicine.
Despite continuing to petition the US Supreme Court in an attempt to protect a precedent allowing generic drugmakers to market a patented brand name drug for certain indications under a “skinny” label, new research raises concerns about billions of dollars in savings if courts don’t decide to protect skinny biosimilar labels.