Samsung Bioepis will be unable to sell Eticovo, a biosimilar of autoimmune disease treatment, Enbrel (Ingredient: etanercept), in the U.S. until 2029 as the company lost a patent lawsuit with its developer Immunex.

According to industry insiders, the New Jersey district court ruled in favor of Amgen, Immunex, and Roche in the Enbrel patent infringement lawsuit on Nov. 3, disallowing Samsung Bioepis to manufacture, sell, and import Eticovo to the United States.

As a result, Samsung Bioepis will not be able to market Eticovo in the U.S. until April 24, 2029, when Enbrel-related patents are set to expire.

The ruling marks the second patent setback for an Enbrel biosimilar this year after Amgen won a similar lawsuit against Sandoz in May. At the time, the U.S. Supreme Court ruled that Amgen, the parent company of Immunex, had exclusive sales rights for its products in the U.S. until 2029. The New Jersey court also sided with the plaintiff, citing the Supreme Court's ruling.

"Samsung Bioepis and Amgen have agreed on a permanent injunction in the U.S. regarding the etanercept product," a Samsung Bioepis official said to Korea Biomedical Review. "According to the agreement, the company will not manufacture, sell, import, in the United States until the patent expiration of the etanercept product substance."

The ruling comes as a setback for Samsung Bioepis. The company had high hopes of selling the treatment in the U.S. after it ranked first in market share in the European etanercept market and surpassed Amgen's Enbrel four years after its launch in Europe. Biogen, the company's EU partner, has marketed the treatment under the brand name Benepali since 2016.

In the first half of this year, it recorded $243.2 million in sales in the EU, maintaining the top market share while widening its sales gap with Enbrel.

The company received product approval for Eticovo in the U.S. in 2019.

Enbrel is a blockbuster drug with sales of $5 billion last year and treats rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis.