- Boehringer Ingelheim GmbH on Friday received approval from the Food and Drug Administration for its drug Cyltezo, opening the U.S. market to yet another biosimilar to AbbVie Inc.'s blockbuster inflammation product Humira.
- The drug is the sixth copycat biologic to gain the FDA OK and the second that references Humira. Cyltezo holds the same seven indications as AbbVie's medication, including rheumatoid arthritis, juvenile idiopathic arthritis and ulcerative colitis.
- Though AbbVie has faced biosimilar competition in the past with the approval of Amgen Inc.'s Amjevita, the Illinois-based drugmaker has successfully kept those threats at bay through effective patent litigation. Humira sales reached more than $4.7 billion between April and June, a nearly 14% increase from the same period in 2016.
Unlike Europe, the U.S. is still getting its sea legs as it sails deeper into biosimilar waters. Though the pharmaceutical industry expects the copycat biologics to disrupt stateside markets in similar fashion to how generics changed the game for branded medicines, so far that hasn't happened.
Novartis International AG's Zarxio (filgrastim-sndz), which references Amgen's Neupogen (filgrastim), was the first biosimilar to gain FDA approval back in early 2015. Since then, U.S. regulators have given the green light to just a handful of other biosimilars, and most of those haven't been able to return substantial profits due to legal battles preventing their market access.
Case in point is Amgen's Amjevita (adalimumab-atto), the first FDA-approved biosimilar to Humira (adalimumab). Despite the drug receiving a thumbs up almost a year ago, it hasn't launched because of an AbbVie-filed patent infringement lawsuit. Amgen, in turn, has filed counterclaims against that lawsuit, the trial date for which is set for Nov. 4, 2019, according to biotech's most recent 10-K form submitted to the Securities and Exchange Commission.
Boehringer looks to be facing a similar issue with its new product. The German pharma is involved in patent litigation with AbbVie concerning Cyltezo, and therefore isn't currently commercializing the drug, according to an Aug. 29 statement.
What Boehringer has going for it, though, is that while AbbVie has been adept at using the court system to quash biosimilar competition, the strategy hasn't been full proof. In May, for instance, the U.S. Patent and Trademark Office ruled in favor of Coherus Biosciences Inc., which sought to invalidate one of Humira's many patents.
Nonetheless, AbbVie investors appear confident in the company's Humira defenses. Its stock was essentially unchanged on Friday, up less than 1% to $72.48 per share by close of market. Amgen shares were also unphased amid the Cyltezo approval, down less than 1% to $169.74 apiece.
AbbVie didn't respond to BioPharma Dive requests for comment, while Amgen declined to comment.
In spite of the legal blockades, this latest approval gives Boehringer its first U.S. biosimilar victory as well as a large patient population to tap into once commercialization becomes viable. The company anticipates a decision for its European filing of Cyltezo by year's end.