Initially authorized by the FDA in 1998, Amgen’s Enbrel continues to operate without encountering biosimilar competitors in the U.S. The patent protection for the inflammatory disease drug will be maintained by the Southern California firm until 2029, notwithstanding any ruling to the contrary by a court.
Sandoz, which specializes in Swiss generics and biosimilars, seeks to put a spanner in the works, as it has filed an antitrust case in federal court in Virginia, alleging that Amgen has obstructed competition to illegally prolong its monopoly, as stated in the complaint.
Amgen, as per the suit, seemingly accomplished this by acquiring patent rights from its competitor, Swiss pharmaceutical powerhouse Roche, which was formulating a medicine from the same therapeutic class to rival Enbrel. If these patents hadn’t been there, Enbrel would have faced opposition from biosimilars in Europe starting in 2016.
Sandoz wants an injunction to prohibit Amgen from using patent rights to hinder biosimilar competition. The company aims to expedite the introduction of its Enbrel biosimilar, Erelzi while also seeking treble damages, which may be increased under antitrust legislation.
This is not the first time Sandoz and Amgen have locked horns over patent rights for Enbrel. In 2019, a New Jersey court found in favor of Amgen in the patent dispute, which concluded in 2021 when the U.S. Supreme Court declined to review the case. In the same year, Amgen achieved a favorable court ruling that prohibited Samsung Bioepis from introducing its Enbrel biosimilar, Eticovo.
After Sandoz’s biosimilar Erelzi was approved by the FDA in 2016, the company launched it in Europe in 2017.
To show the impact of biosimilar rivalry in Europe, Pfizer said that its Enbrel sales outside the U.S. and Canada reached a high point of $3.8 billion in 2014, subsequently diminishing to $3.3 billion and $2.9 billion in the ensuing two years. By the previous year, Enbrel sales had dropped to just under $700 million.
Sandoz said in the complaint that after one year of Erelzi’s introduction in Europe, Enrel’s price had halved, and biosimilars accounted for 40% of the market share.
Enbrel’s patent protection is still valid in the U.S., where Amgen reported sales of $3.3 billion last year, a decline from $5.2 billion in 2019, due to competition from other medications lowering Amgen’s market share for this product.
Ingrid Sollerer, general counsel of Sandoz, said that it is early to determine the amount the firm is pursuing but indicated that the company is assessing earnings lost since the prospective market launch.
She noted that while people living in South America, Europe and Canada have had access to Enbrel biosimilars for about ten years, patients in the U.S. are being denied access to these cost-effective alternatives.
