Originally approved by the FDA in 1998, Amgen’s Enbrel is still sailing along without facing biosimilar competition in the United States. And unless a court rules otherwise, the Southern California company will retain its patent protection on the inflammatory disease medicine until 2029.
Hoping to alter the timetable is Swiss generics and biosimilars specialist Sandoz, which has filed an antitrust lawsuit in federal court in Virginia claiming that Amgen has blocked competition to “unlawfully extend its monopoly,” according to the complaint.
Amgen, according to the lawsuit, allegedly did this by purchasing patent rights from one of its competitors, Swiss pharma giant Roche, which was developing a product from the same drug class to compete with Enbrel. Without these patents, Enbrel would have been subject to competition from biosimilars—as was the case in Europe—by as early as 2016.
Sandoz is seeking an injunction preventing Amgen from using the patent rights to block biosimilar competition. Sandoz wants to launch its Enbrel biosimilar Erelzi as soon as possible. The company also is pursuing treble damages, which could be tripled, according to antitrust law.
This isn’t the first go-round for Sandoz and Amgen over patent protection for Enbrel. In 2019, a New Jersey court ruled for Amgen in the patent fight, which died in 2021 when the U.S. Supreme Court refused to hear the case. That same year, Amgen was victorious in another court decision, which denied Samsung Bioepis from launching its Enbrel biosimilar Eticovo.
Sandoz earned its FDA approval for Erelzi in 2016 and launched the biosimilar in Europe the following year.
To illustrate the effect of biosimilar competition in Europe, Pfizer reported its Enbrel sales outside of the U.S. and Canada peaking at $3.8 billion in 2014 before declining to $3.3 billion and $2.9 billion in the following two years. By last year, those Enbrel sales had shrunk to $690 million.
In the lawsuit, Sandoz said that within a year of Erelzi’s launch in Europe, the price of Enbrel had declined by 50% and biosimilars held 40% of market share.
In the U.S., where Enbrel’s patent protection remains intact, Amgen reported its sales at $3.3 billion last year, which were down from $5.2 billion in 2019 as competition from other products have reduced Amgen’s market share for the product.
Between 1998 and 2004, Enbrel was approved in the U.S. for rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis.
In 2018, the Initiative for Medicines, Access and Knowledge (I-MAK) issued a report (PDF) on Enbrel titled “Enbrel: Overpatented, Overpriced Special Edition.” The report said that 72% of the 57 patents filed on Enbrel in the U.S. were done so after it was initially approved by the FDA.