Sandoz, the generics arm of drug giant Novartis ($NVS), launched a Phase III study for its biosimilar of Enbrel with great fanfare today, boasting of a market-leading slate of 7 late-stage biosimilar studies on 5 molecules.
While the FDA has fallen well behind Europe in laying out a full regulatory pathway for biosimilars, Sandoz says it designed this new study of the Enbrel knockoff with direct input from regulators on both sides of the Atlantic. And it's been aggressively pushing ahead on the biosimilar front as rivals fall by the wayside, with ambitious projects sidelined by patent issues and the very high financial threshold for providing convincing late-stage data that the knockoffs work just as well as the branded originals.
Sandoz is taking aim at patients with moderate to severe chronic plaque-type psoriasis, rather than the megablockbuster indication for rheumatoid arthritis. Psoriasis will likely prove a simpler target for Sandoz, which can broaden the work as it gains experience testing the treatment. But it faces some big hurdles in the U.S. if it expects to garner a big market for the treatment. In the fall of 2011 Amgen ($AMGN) said it had landed a new patent on Enbrel that would ward off biosimilar competition for up to 17 years, well past the 2012 expiration of its central patent. Soon after, Merck ($MRK) said it was halting its own biosimilar effort on Enbrel and later signed on as a marketing partner for a joint venture between Biogen Idec ($BIIB) and Samsung.
That was one of several setbacks in the field. Lonza CEO Richard Ridinger--who was working with Teva on a knockoff of Rituxan--told reporters a few months ago that he wasn't sure if the business model on follow-ons still worked as initially expected. Four years ago, he added, it looked like you could develop a knockoff biosimilar for a mere $105 million. But costs have evidently soared, or at least the reality of mounting a full, late-stage trial required by regulators has set in. And the new math, in a world where late-stage studies often cost hundreds of millions of dollars to complete, requires a lengthy gut-check.
Sandoz, however, appears to be undaunted. A spokesperson says that its 5 treatments in Phase III are Filgrastim (Amgen's Neupogen, being readied for a U.S. filing); Epoetin alfa (Procrit/Epogen for the U.S. and E.U.); Etanercept (Enbrel); PegFilgrastim and Rituximab for follicular Lymphoma.
"The continued increase in spending on biological agents for treatment of immune-mediated diseases such as rheumatoid arthritis and psoriasis is a growing concern among physicians in many developed and developing countries," said Alan Menter, chairman of the division of dermatology at Baylor University Medical Center in Dallas. "A high-quality and clinically-proven biosimilar version of etanercept could play an important role in generating much-needed savings for healthcare systems that can be used to fund novel therapies or treat more patients."
- here's the release from Sandoz
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