Novartis' Sandoz Unit Working On Copy Of Roche Drug - Source
Published December 09, 2010 | Dow Jones Newswires
ZURICH -(Dow Jones)- Novartis AG's (NVS) generics unit Sandoz is close to starting mid-stage patient trials for its copy of Roche Holding AG's (ROG.VX) cancer and rheumatoid arthritis drug Rituxan, which is also known as Mabthera, a person familiar with the company told Dow Jones Newswires.
Spokespeople for Novartis and Sandoz declined to comment.
Jeff George, head of Sandoz, recently told Dow Jones Newswires in an interview the company has around 8 to 10 molecules in its biosimilars pipeline, including monoclonal antibodies. But George declined to say which of the currently patent-protected complex biological drugs Sandoz is trying to copy.
Generic companies such as Sandoz are understood to attack the market for complex biotech drugs, known as biosimilars, as many of these expensive and profitable drugs are expected to lose patent protection.
Sandoz's competitor Teva Pharmaceuticals Industries Ltd. (TEVA, TEVA.TV), which has linked up with Swiss biochemicals producer Lonza Group AG (LONN.VX), earlier this year said it has begun testing of Rituxan, which is also sold by Biogen Idec Inc (BIIB).
"Sandoz has done research on Rituxan and has already done phase I clinical trials," the person, who declined to be named, told Dow Jones Newswires. "The company is expected to soon start phase II trials," the person added.
Rituxan, which had sales of around 6 billion Swiss francs in 2009, is scheduled to lose patent protection in some markets in 2014.
The market for biotech generics is set to become red hot. According to Datamonitor, sales could reach more than $2 billion by 2014. By 2020, the market could grow "well over $20 billion", according to estimates provided by Sandoz.
According to Michael Frizberg, vice president of Lonza Generics, the market potential is huge given that many complex biological cancer drugs--such as Roche's Avastin, Herceptin or Merck KGaA's (MRK.XE) Erbitux--have extremely high prices.
The high price prevents many patients receiving reimbursement and thus using these drugs, Frizberg said, adding that some 84% of people who may stand to benefit from Roche's Avastin, for example, remain untreated due to the high price.
Many analysts remain cautious about the nascent biosimilar market's potential outlook, however, given that costs to research and develop a complex biological drug can run as high as $200 million.
They also say it's unclear whether physicians and patients will embrace biosimilar drugs, given that the complexity of producing such medicines could raise substantial safety issues.
European drug regulators recently drafted guidelines for the biosimilar market, asking for similarly rigid research and development procedures as that for the production of a novel drug. In contrast, copycat versions of chemical drugs, simply known as generics, are much cheaper to research and develop.
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