The FDA has started its review of the first biosimilar of Amgen’s immunotherapy blockbuster Enbrel, filed by Novartis’ generics unit Sandoz.
Sandoz said it was seeking approval for all the indications covered in the labelling for Enbrel (etanercept) – including rheumatoid arthritis, psoriasis and psoriatic arthritis – and believes it is the first company to file for approval of a biosimilar of the drug in the US.
Enbrel is a drug in the tumour necrosis factor (TNF) inhibitor class and is currently Amgen’s second biggest-selling drug, bringing in $2.46bn in the first six months of this year, a rise of 10% on the first half of 2014.
The FDA will now start a 10-month review process for the biosimilar, suggesting that approval could be forthcoming in the middle of 2016, although a launch will depend on the outcome of patent litigation between the two companies.
Sandoz was the first company to get approval for a biosimilar drug under the FDA’s 351(k) approval pathway, getting the go-ahead in March for Zarxio (filgrastim-sndz), a competitor to Amgen’s Neupogen (filgrastim) brand. Zarxio was launched a few weeks ago at a 15% discount to the reference product.
In markets outsider the US – where it is known as Zarzio and has been available since 2006 – Sandoz’ drug has captured around a 30% share of the Neupogen market.
Biosimilar versions of Enbrel have started to appear outside the US too, with Merck & Co and Samsung Bioepis getting approval in South Korea last month for their Brenzys version. Meanwhile, in 2013, Indian drugmaker Cipla said it had launched its own Etacept version in its home market at a 30% discount to the brand.
In the US, bringing biosimilar Enbrel to market will hinge on Sandoz being able to overturn patent on Enbrel that Amgen says protect it from biosimilar competition until 2029, more than 30 years after the drug was first launched onto the market. The original patent on Enbrel was set to expire on October 23, 2012.