Novartis' Sandoz unit has become the first company to win approval in the US for a biosimilar version of Amgen's big-selling TNF inhibitor Enbrel.
Sandoz's drug - called Erelzi - has been approved for all the indications covered in the label for Enbrel (etanercept), including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.
The decision follows a unanimous vote by an FDA advisory committee in July in support of the new drug, and is the second approval in the US for Sandoz' emerging biosimilars business after the company got a green light for its Zarxio copy of Amgen's neutropenia therapy Neupogen (filgrastim).
A launch is unlikely to take place anytime soon, however, unless Sandoz chooses to introduce the drug 'at-risk', ahead of the verdict in a patent infringement lawsuit filed by Amgen in March. Amgen is still claiming patent protection for its drug in the US market out to 2029.
The US biosimilar market is still in its infancy with just two products approved to date, namely Zarxio and Pfizer's Inflectra, a version of Johnson & Johnson's TNF inhibitor Remicade (infliximab) that is sold as Remsima in other markets.
Assuming the US follows the scenario unfolding in Europe - where biosimilars have been available for a decade with more than 20 products approved to date - it is expected that new biosimilar launches will be priced at a 30-50% discount to the originator brand.
In some cases - for example in Norway where Remsima is priced at a 70% discount to Remicade - the branded product been largely displaced from the market.
A marketing application for Sandoz's biosimilar etanercept has been accepted by the European Medicines Agency (EMA) and is currently undergoing review, with a decision expected before the end of the year.
The first and currently only Enbrel biosimilar to be approved in the EU was Samsung Bioepis' Benepali, which got the go-ahead from the EMA in January.