Amgen Scores Victory Over Novartis in Etanercept Biosimilar Appeal

Pharmaceutical giant Amgen won a ruling in a federal appeals court today against Novartis AG’s Sandoz, preventing the latter from selling a biosimilar of Amgen’s rheumatoid arthritis (RA) drug Enbel (etanercept).

The U.S. Federal Circuit Court of Appeals in Washington, D.C., ruled 2-1 in Amgen’s favor, blocking Sandoz from selling a biosimilar for almost 10 years. The ruling today upholds a previous one made in August 2019 by a district judge in New Jersey.

Sandoz sought to invalidate Amgen’s two patents and market its biosimilar Erelzi, which received Food and Drug Administration (FDA) approval in 2016. However, the patents cover etanercept and the methods for making it, with one patent expiring in November 2028 and the other in April 2029.

However, the ruling today may not be the end of the battle for Sandoz.

“Sandoz will continue its efforts to make Erelzi available to US patients with autoimmune and inflammatory diseases,” said Carol Lynch, president of Sandoz US and Head of North America, in a press release. “Our company respects valid intellectual property, however Sandoz continues to believe the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity.”

Etanercept: History, Profitability, and Indications

Etanercept is reportedly Amgen’s biggest seller. In 2019, of the company’s $22.2 billion in sales, $5.23 billion was attributed to etanercept – nearly a quarter of the total revenue.

The drug received FDA approval in 1998. It was manufactured by Immunex Corporation, which Amgen acquired several years after etanercept was approved.

In addition to RA, etanercept is also indicated to treat polyarticular juvenile idiopathic arthritis (JIA) in patients aged two years or older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and plaque psoriasis (PsO) in patients aged four years or older.

In adults with RA and PsA, etanercept is recommended in 50 mg once weekly with or without methotrexate. In AS, it is recommended in a 50 mg dose once weekly. In adults with PsO, it is recommended at 50 mg twice weekly for three months and then 50 mg once weekly thereafter. Pediatric PsO and JIA patients are recommended to take 0.8 mg/kg weekly with no more than 50 mg weekly.