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Home Industry News Sandoz’s biosimilar etanercept candidate shows efficacy in new trial

Sandoz’s biosimilar etanercept candidate shows efficacy in new trial

7th July 2016

Sandoz has announced findings from a new clinical study called EGALITY that further demonstrate the benefits of its new biosimilar etanercept candidate.

The study, which compared the safety and efficacy of the etanercept biosimilar with the originator product Enbrel in patients with moderate to severe chronic plaque-type psoriasis, was able to meet its primary efficacy endpoint.

Sandoz's biosimilar was able to provide equivalent efficacy to the originator product at week 12, with the incidence rate of adverse events also proving similar. This was the first safety and efficacy study to compare branded etanercept to a biosimilar candidate in psoriasis.

Evidence from this trial will be used to support Sandoz's efforts to secure regulatory approval for the drug across all indications included on the label of the originator product.

The product was accepted for regulatory review by the European Medicines Agency and the US Food and Drug Administration in the second half of 2015.

Malte Peters, head of global clinical development for biopharmaceuticals at Sandoz, said: "If our biosimilar etanercept is approved for the same indications as the originator product, more patients with chronic inflammatory conditions like rheumatoid arthritis and psoriasis will have access to life-changing biologic treatment options."ADNFCR-8000103-ID-801821482-ADNFCR

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