Novartis' Enbrel biosimilar closer to market

Amgen/Pfizer’s blockbuster Enbrel (etanercept), could have cheaper competition from Novartis, after a key US committee recommended approval.

The FDA’s Arthritis Advisory Committee voted unanimously in support of the biosimilar,  from Novartis’ Sandoz generics and biosimilars unit, for all five indications of the reference product.

These include rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

Although advisory committee votes are not binding, the FDA usually follows their lead when deciding whether to approve or reject drugs.

Novartis said the committee made its recommendation based on evidence from a global development programme, showing its drug was “highly similar” to Enbrel.

The committee earlier this week recommended a biosimilar, made by Amgen, of the world’s biggest selling drugs, AbbVie’s Humira (adalimumab), for rheumatoid arthritis and other diseases.

Amgen therefore looks set to fight several legal patent battles at once – defending Enbrel, attacking AbbVie in order to launch its Humira rival, and a third legal case where it is attempting to get Sanofi-Regeneron’s rival cholesterol Praluent pulled from the market.

In 2015, Enbrel pulled in $5.4 billion in sales for Amgen – and like AbbVie with Humira, Amgen will surely defend its drug vigorously in courts, having added to its patent defences in a bid to prevent competition.

Although the original Enbrel patent ran out in 2012, Amgen has taken out another patent that it says will prevent competition until 2029.

Johnson & Johnson’s Remicade (infliximab) anti-TNF also faces biosimilar competition after a rival from Celltrion was approved earlier this year, but this has yet to be launched because of patent defences.

Biosimilars are near-copies of biologic drugs that are made in cells, and may vary slightly from the originator drug.

Regulators in the US and EU have set up separate, but rigorous regulatory pathways for biosimilars , but the US is lagging behind the EU in terms of launches so far.