Novartis receives FDA approval for Erelzi as a biosimilar of Amgen's Enbrel

Novartis' Sandoz unit on Tuesday announced that the FDA authorised Erelzi (etanercept-szzs) as a biosimilar version of Amgen's Enbrel (etanercept) for all indications for which the original product is approved. The agency's approval follows a unanimous vote by an FDA advisory panel backing clearance of the drug last month.

The approval was supported by data from a global development programme, including analytical, preclinical and clinical studies. Clinical trials included four comparative pharmacokinetic studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis. Erelzi, which the Swiss drugmaker noted is "the first biosimilar etanercept approved by the FDA," is also the second biosimilar from Novartis to receive approval in the US. Zarxio (filgrastim-sndz) was launched in the country last year as a biosimilar of Amgen's Neupogen (filgrastim).  

The Swiss drugmaker has previously identified Erelzi, previously known as GP2015, as one of five biologics it hoped to launch by 2020. Meanwhile, a European submission for the biosimilar was accepted for review in the fourth quarter of last year.

Enbrel was approved in 1998 and generated $5.1 billion in US sales last year, with Amgen asserting that the product has patent protection until 2029. Under a court order dated August 11, Amgen and Sandoz agreed to a preliminary injunction blocking the launch of Erelzi. Morgan Stanley analyst Matthew Harrison recently said that the agreement indicates that a trial would not begin until April 2018, suggesting that a near-term launch of Erelzi "is off the table."

For related analysis, see ViewPoints: How the FDA learned to stop worrying and love biosimilars, and KOL Views: Is it a question of 'when' rather than 'if' there is a biosimilars explosion in the US market? For additional information about the biosimilar market, read Biosimilar Index: Tracking the Biosimilar Development Landscape. 




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