Enbrel unlikely to face Novartis rival until 2018

There’s an in-joke in the industry that Amgen is best described as a legal company with a pharmaceutical arm – and recent developments show it is living up to its litigious reputation.

Amgen is embroiled in a series of legal disputes over patents covering biosimilars. In one case Amgen is trying to keep a cheaper Novartis near-copy off the market, while in another it is launching its own biosimilar of AbbVie’s Humira.

Amgen’s excellence in legal matters has just been confirmed, after it won a ruling which will see Sanofi’s Praluent removed from the US market because of a patent infringement.

However the company can’t keep competition at bay indefinitely: Novartis has just confirmed that its biosimilar of Amgen’s psoriasis drug Enbrel will be on sale in the US from 2018.

Richard Francis, head of Novartis’ Sandoz generics business, told Reuters that Amgen is arguing in a US court that Enbrel, with sales of $4.7 billion a year, has patent protection until 2029.

The FDA has approved Sandoz’s biosimilar of Enbrel (etanercept), called Erelzi, for inflammatory diseases including rheumatoid arthritis, plaque psoriasis and ankylosing spondylitis.

Francis said the legal tussle over Enbrel will last for another year at least.

Sandoz's Richard Francis

Sandoz’s Richard Francis

“That won’t really reach a conclusion until 2018,” he told Reuters. “That’s the frustration sometimes of the legal situation, but the way I look at that, we’re carving the landscape out as we go.”

Novartis and Amgen are also involved in a separate legal case, on whether biosimilar companies must wait 180 days after FDA approval before beginning sales of biosimilars.

Amgen is also involved in a legal fight with AbbVie in a bid to get its own biosimilar of rheumatoid arthiritis drug Humira (adalimumab) on the US market.

AbbVie has a lot to lose with the challenge to Humira, which generated $14 billion in 2015, and the US accounting for around 60% of sales.

The FDA approved Amjevita in September but Amgen cannot launch its cheaper biosimilar because of ongoing patent litigation.

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