Sandoz initiates Ph III trial for biosimilar Enbrel

Swiss drug major Novartis’ (NOVN: VX) generics unit Sandoz has initiated a major Phase III clinical trial with its biosimilar version of US biotech leader Amgen's Enbrel (etanercept), which last year generated worldwide sales of $4.23 billion for Amgen.

The global clinical trial will seek to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis. The global clinical program was developed in consultation with regulatory authorities in the USA and European Union, and the results from this clinical trial are expected to support regulatory submissions in both the USA and EU.

"Sandoz has a strong track record in developing and commercializing biosimilars around the world," said Ameet Mallik, head of biopharmaceuticals and oncology injectables at Sandoz, adding: "We will leverage this experience and our industry-leading capabilities to bring a biosimilar version of etanercept to patients and physicians around the world."