By Sy Mukherjee
October 31, 2018

Happy hump day—and Happy Halloween—readers!

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.

Sy Mukherjee


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