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biosimilar - Articles and news items


FDA approves Novartis’ biosimilar to treat multiple inflammatory diseases

Industry news / 1 September 2016 / Niamh Louise Marriott, Digital Content Producer

The FDA approval is based on analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis…


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