Amgen snags big win in ongoing biosim battle

Dec. 1, 2021

A U.S. District Court has ruled in favor of Amgen in a patent litigation case involving the drug Enbrel, preventing Samsung Bioepis from bringing its etanercept biosimilar (Eticovo) to market in the U.S. until 2029.

The District of New Jersey agreed with the contention made by Amgen, Roche (the original patent holder) and Amgen subsidiary, Immunex, that Samsung Bioepis would infringe two key patents if it attempted to produce, sell or import to the U.S. its biosimilar prior to 2029, which is when the patents expire.

The reference product, Enbrel, is a tumor necrosis factor (TNF)–inhibitor approved for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and pediatric plaque psoriasis. The drug got its first FDA nod in 1998, but its five patents were issued well after its regulatory approval, in 2011 and 2012. According to The Center for Biosimilars, filing patents subsequent to FDA approval extends the product exclusivity life of an originator drug, and in this case, Enbrel will end up with 31 years of exclusivity in the U.S.

The court decision marks the second win for Amgen in the battle to fend off biosimilar competition. Last May, the U.S. Supreme Court declined to reopen a Federal Circuit patent case between Amgen and Sandoz, who had unsuccessfully sought to bring its own etanercept biosimilar, Erelzi, to market prior to 2029.