BioCentury
ARTICLE | Clinical News

Sandoz starts Phase III testing of etanercept biosimilar

June 25, 2013 12:45 AM UTC

Sandoz started an international Phase III trial to evaluate a biosimilar of autoimmune drug Enbrel etanercept to treat moderate to severe chronic plaque-type psoriasis. The generics unit of Novartis AG (NYSE:NVS; SIX:NOVN) said data from the trial are expected to support regulatory applications for the biosimilar in the U.S. and EU.

Amgen Inc. (NASDAQ:AMGN) and Pfizer Inc. (NYSE:PFE) co-market Enbrel in the U.S. and Canada, while Pfizer has rights elsewhere. The recombinant p75 TNF receptor linked to the Fc portion of human IgG1 (TNFr:Fc) is approved to treat rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Amgen reported $4.2 billion in 2012 worldwide Enbrel sales. The last U.S. patents covering Enbrel expire in 2028 and 2029. A Novartis spokesperson said Sandoz believes "it has a good faith legal basis to challenge the validity" of the patents. ...