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FDA approves Novartis’ biosimilar to treat multiple inflammatory diseases

1 September 2016 | By 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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Novartis’ phase III MS study successfully meets endpoints

25 August 2016 | By Novartis

The study included 1,651 people with SPMS randomised to receive either 2mg BAF312 or placebo in a 2:1 ratio respectively, the primary endpoint being an improvement in the time to three-month confirmed disability progression, as measured by the expanded disability status scale (EDSS), versus placebo...