Brainstorm Health: Humira Biosimilar Approval, Bionic Arm, Juul and Schools

In 2017, one single drug pulled in a staggering $18.4 billion in global sales (including $12.4 billion in the U.S.). It’s AbbVie’s Humira (you may have heard it from the ubiquitous television ad blitzes for the psoriasis and arthritis treatment).

On Wednesday, Sandoz, the generic drug arm of Swiss pharmaceutical giant Novartis, announced that the Food and Drug Administration (FDA) had approved its “biosimilar” copycat of Humira, a therapy called Hyrimoz (or adalimumab-adaz). That’s theoretically good news for patients given that biologic drugs like Humira come with massive list price tags—but in case, there’s a catch.

“With the FDA approval of Hyrimoz, Sandoz is one step closer to offering US patients with autoimmune diseases the same critical access already available in Europe,” said Stefan Hendriks, global head of biopharmaceuticals at Sandoz, in a statement.

The latter part of Hendriks’ statement is telling. Humira biosimilars have been available in other countries for some time now. In the U.S., however, AbbVie has struck deals to effectively keep competitors off the market (including Novartis’ newly approved therapy) for another five years—a significant extension for what’s a $13 billion per year drug domestically.

In fact, Hyrimoz, and whatever discount the treatment will ostensibly bring to the health system, won’t hit the U.S. until late 2023. “On October 11, 2018, Sandoz announced a global resolution of all intellectual property-related litigation with AbbVie concerning all indications of the proposed Sandoz biosimilar adalimumab for the reference medicine. The license enables patient access in the US to Hyrimoz (or Sandoz adalimumab or Sandoz biosimilar) as of September 30, 2023.”

With competitors coming for its flagship medicine, AbbVie has been under pressure to produce a new generation of therapies to fill the eventual, if delayed, void.

Read on for the day’s news.

DIGITAL HEALTH

A click on bionic arm. Reuters reports that Austrian scientists have been experimenting with a technology that allows for a "click on" bionic arm for amputees. Through a procedure called "osseointegration," an implanted metal rod connects the prosthesis to bone and relay messages to the device (the surgery also involves repurposing existing nerves to carry out these duties). One company working on such technology had this to say about it: "We think of it like a USB connector from the body." (Reuters)

INDICATIONS

GSK's steady march into oncology. New GlaxoSmithKline CEO Emma Walmsley has already made her mark on the drug giant by shuffling up the R&D division and significantly shifting its focus. She's not showing any signs of stopping. The firm, primarily known for its flagship HIV and respiratory drug portfolios, is marching steadily into the cancer research space (in which it has lagged most of its rivals for years). To that end, GSK is dumping perceived losers, especially in the respiratory sector, at a rapid clip, including one for COPD, one for chronic cough, and one for mild asthma.

THE BIG PICTURE

Report: Juul offered up cash to sponsor a controversial vaping curriculum. Flagship vaping company Juul reportedly offered to pay public schools up to $20,000 to introduce anti-vaping curriculums that appeared to lay the blame for a massive surge in youth vaping on peer pressure, according to BuzzFeed News. Here's what experts writing in the Journal of Adolescent Health had to say about that curriculum: "The JUUL Curriculum’s approach to addressing the risk of e-cigarettes is insufficient because it neglects to present information on nicotine levels in JUULs, which is very high. Therefore, the JUUL Curriculum is not portraying the harmful details of their product, similar to how past tobacco industry curricula left out details of the health risks of cigarette use." A Juul spokesperson told Fortune, "We do not want any young person—or non-nicotine user—to ever use JUUL. We only want to implement initiatives that will help current adult smokers switch to JUUL, while ensuring young people do not access our product." (Fortune)

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