On Monday, Sandoz announced that it had filed an antitrust lawsuit in the U.S. against Amgen, the blockbuster drug manufacturer of Enbrel (Etanercept).
Enbrel, a blockbuster drug, made $3.3 billion in the U.S. market last year.
Etanercept, the active ingredient in Enbrel, is a crucial autoimmune disease treatment for various severe inflammatory conditions.
Sandoz alleges that Amgen unfairly obtained specific patents to block the market entry of its biosimilar product, Erelzi (Etanercept), and leveraged these patents to cement its market dominance.
Despite receiving the Food and Drug Administration’s (FDA) approval for Erelzi in 2016, Sandoz has been unable to launch the product in the U.S. until 2029 due to a patent dispute with Amgen.
Other biosimilar companies face similar hurdles. Samsung Bioepis, for instance, secured U.S. approval for its Enbrel biosimilar, Eticovo (Etanercept), in 2019 but remains sidelined due to ongoing patent litigation with Amgen.
Sandoz contends that this situation deprives approximately 7.5 million patients with chronic inflammatory conditions – including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis – of the cost savings and improved treatment access that biosimilars could offer.
In response, Sandoz has filed a lawsuit in the U.S. District Court for the Eastern District of Virginia.
The company seeks a preliminary injunction to prevent Amgen from wielding specific patents to block competing biosimilars, aiming to expedite Erelzi’s market entry.
Additionally, Sandoz is pursuing compensation of damages that could potentially triple under antitrust laws.
In contrast to the U.S. market, Enbrel biosimilars have been available in Europe since 2016, where they now outpace the original drug in prescription volume.
Samsung Bioepis’s Benepali (marketed as Eticovo in the U.S.) leads the European etanercept market, while Enbrel’s share has dwindled to approximately 20%.