Drugs

‘Skinny Labels’ Lead to Earlier Competition: Study

Researchers from Harvard University and West Virginia University College of Law say the use of so-called skinny labels “led to years of earlier competition for five biologics through 2021, with estimated savings to Medicare of $1.5 billion through 2020.” Writing in JAMA Internal Medicine, the researchers say that although biologics comprise fewer than 5% of prescription drug use, they account for some 40% of U.S. drug spending. The researchers predict that the Medicare savings will grow considerably once AbbVie’s Humira (adulimumab) faces competition from skinny label biosimilars in 2023.

The researchers say that biologics manufacturers often take steps to delay the availability of biosimilars. To help prevent this source of potential delay, they say, the law permits FDA to approve “skinny label” generic drugs and biosimilars that carve out indications protected by patents or regulatory exclusiveness. The study looked at the frequency of approval and marketing of skinny-label biosimilars and their savings to Medicare.

“Skinny labeling for biosimilars is important to ensure timely competition for biologics, helping make these medications more affordable and accessible,” the researchers conclude.

The article says the researchers wanted to look at the impact of skinny labels since recent court rulings are threatening the pathway. In a Teva case that has made it to the Supreme Court involving GlaxoSmithKline’s heart drug Coreg (carvedilol), the court has invited the federal government to submit a brief expressing the government’s views. Teva asked the court to answer this question: If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome