Amgen wins latest round in legal tussle over Enbrel patents

Amgen’s reputation as a fearsome adversary in the courtroom remains intact after it won the latest round in a legal tussle with Sandoz over the patent covering the blockbuster inflammatory diseases drug Enbrel. 

The appeals court ruling blocks Sandoz from producing a biosimilar of Enbrel (etanercept) until 2029, more than thirty years after it was first approved. 

Sandoz, which is the biosimilars and generics unit of Novartis, said it is “reviewing its options” following the decision from the New Jersey District Couty. 

The Enbrel biosimilar, which is branded as Erelzi, was approved by the FDA in August 2016 but Sandoz has been unable to launch the medicine due to the ongoing litigation with Amgen. 

Biosimilars have the potential to save billions in medicines costs in the US, and could free up cash in the US health system that could be spent on newer drugs as well as widening access to biologic medicines. 

As these medicines are produced in cells instead of using chemical processes, they must undergo strict analytical tests and trials to show they are as safe and effective as the original medicine. 

Although they are not sold at the rock-bottom prices of conventional generics, they usually have a considerable discount compared with the originator medicine and may help to drive down prices 

But like many other big pharma companies Amgen's legendary legal team has set up a thicket of patents to protect its biologic drugs in the US, which are proving more difficult to clear than in other territories. 

The court decision will be a relief for Amgen, which still relies on US sales of Enbrel to prop up its revenues. 

In Q2 alone Enbrel generated income of just under $1.4 billion, nearly all from the US where sales are still slowly growing. 

It has been unable to produce a blockbuster to replace Enbrel, which was first approved in 1998 for rheumatoid arthritis, and can also be used in diseases such as psoriatic arthritis and ankylosing spondylitis. 

But Amgen is also producing its own biosimilars to steal market share from its rivals. 

In 2023 Amgen will be the front-runner in a group of companies launching biosimilars of AbbVie’s inflammatory diseases rival Humira (adalimumab) in the US. 

Pfizer owns rights to Enbrel in most other major markets, where sales have diminished elsewhere in the world because of biosimilar competition.