Sandoz begins phase III trial of biosimilar etanercept
24 June 2013 17:30 in Consumer Healthcare News
Sandoz has announced the launch of a phase III trial of its new biosimilar etanercept, for the treatment of moderate to severe chronic plaque-type psoriasis.
This therapy is a biosimilar version of Enbrel, a tumour necrosis factor alpha inhibitor from Amgen that is approved for the treatment of rheumatoid arthritis, psoriasis and other conditions.
Sandoz's clinical programme was developed in consultation with regulatory authorities in the US and EU, with results from the study expected to support regulatory submissions in both territories.
Extensive preclinical and clinical data has demonstrated that the Sandoz biosimilar is highly similar to Enbrel, thereby justifying the progression to phase III testing.
Dr Mark McCamish, the company's head of global biopharmaceutical development, said: "Sandoz remains steadfast in its commitment to significantly increase worldwide access to essential, high-quality and life-enhancing biopharmaceuticals."
The firm's portfolio of around 1,100 medicines is currently available to more than 90 percent of the world's population.
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Story collated for Zenopa by the Axonn News Agency