- Novartis AG aims to win U.S. approval for what would be the third biosimilar of AbbVie Inc.'s world-beating drug Humira, announcing Tuesday through its generics unit Sandoz that the Food and Drug Administration has accepted an application for its version of the biologic.
- Sandoz has launched five biosimilars worldwide and sells a copy of Amgen Inc.'s Neupogen in the U.S., where only three of the copycat drugs are actually commercially marketed due to legal roadblocks that have slowed other biosimilars OK'd by the FDA.
- Humira, which last year earned more than $16 billion for AbbVie, is a prime target for biosimilar competition. But AbbVie has surrounded the inflammatory disease drug with a thicket of patents to defend its lucrative market.
While two biosimilars to Humira (adalimumab) are already approved, AbbVie doesn't feel particularly threatened yet. The biopharma doesn't expect to see rivals on the market anytime soon. At the J.P. Morgan Healthcare Conference earlier this month, company CEO Richard Gonzalez indicated biosimilar competition was unlikely to eat into Humira sales until 2022 at the earliest.
In September, AbbVie reached a settlement with Amgen which allows for launch of the latter company's biosimilar in Europe this year, but delays entry of a U.S. version until 2023.
Boehringer Ingelheim also has secured a nod for its own version version of Humira, Cyltezo, which gained FDA approval in August 2017. The Germany company is currently in litigation with AbbVie, and Cyltezo is not currently on the market in the U.S. If the settlement with Amgen is anything to go by, Cyltezo doesn't look likely to reach patients anytime soon.
So — why submit another biosimilar that looks likely to face the same brick wall of AbbVie intellectual property? For one, the size of Humira's market is too big to ignore for any drugmaker committed to launching biosimilars. And, despite the legal hurdles, companies likely aim to lay the groundwork to be ready for a launch as soon as a window opens.
Unlike generics, however, biosimilars have higher costs associated with manufacturing, making the prospects of a crowded race to the bottom on price less appealing for biosimilar developers.