Amgen sues Novartis over Enbrel biosimilar

pharmafile | March 3, 2016 | News story | Research and Development, Sales and Marketing Amgen, Novartis, Sandoz, biosimilars 

Amgen has filed a suit in a US court against Novartis’ generics unit Sandoz, in a bid to protect bestselling arthritis drug Enbrel (etanercept) from Sandoz’s biosimilar competitor.

Amgen filed the suit in the District of New Jersey Court claiming that Sandoz infringed some of Enbrel’s patents by seeking FDA approval for its biosimilar of the drug. The US regulator accepted the new drug application (NDA) for Sandoz’s version in October, and is set to make a decision later this year. Amgen is seeking an injunction that would prevent Sandoz selling its copy if the FDA approves it.  

In the suit, Amgen claims Sandoz is “piggybacking on the fruits of Immunex and Roche’s trailblazing efforts” in creating the drug. Immunex originally developed Enbrel and was later acquired by Amgen, while Roche licenses the patent to Amgen. Amgen also accuses the defendant of using Amgen’s clinical trial data to justify seeking FDA approval of the biosimilar in various indications, despite Sandoz only having conducted trials for it in psoriasis patients.

It is no surprise Amgen is seeking to obstruct biosimilar competition to Enbrel, for which Pfizer holds the rights outside of the US. In Q4 2015 alone, the biologic drug brought in $1.34 billion.

Although the original US patent was set to expire in 2012, Amgen won a second patent the following year, granting 16 more years of exclusivity.

Sandoz has led the way in biosimilars for the American market, last year achieving the milestone of becoming the first company to have a biosimilar approved in the country, with Zarxio – a copy of another Amgen drug, Neupogen (filgrastim). FDA approval for the biosimilar was hard-won, with Novartis overcoming several lawsuits before launching the product in September. The company can expect a similar battle with its etanercept version.

The US has somewhat lagged behind Europe in developing regulatory pathways for the approval of biosimilar drugs. The process had been well established in Europe for more almost a decade, and new FDA Commissioner Robert Califf will hope to see progress made in this regard over the course of his tenure.

Joel Levy 

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