Sandoz: Etanercept biosimilar switch has no impact on safety and efficacy

Approved Biosimilar Products  •  Biosimilar News

Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology.

The 52-week EGALITY study involved 531 adult patients with moderate to severe plaque psoriasis in both switched and continuous treatment arms.  Patients who switched treatments crossed over three times between the biosimilar and the originator product, Enbrel®.  Sandoz, a division of Novartis, said that the treatment switches had no impact on safety and efficacy.

The FDA approved Sandoz’s biosimilar, Erelzi®, in August 2016 for all indications included in the label of the originator product, but it is unclear when Sandoz will launch its product in the United States. It is currently under regulatory review by the EMA.

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