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Japan Approves First-Ever ‘Biosimilar’ Drug

June 25, 2009

Regulators in Japan on Thursday approved the first-ever generic of a biotech drug.

The decision is likely to pave the way “for greater access to high-quality biopharmaceuticals in Japan,” according to Sandoz, Novartis AG’s generics group.

Sandoz’ Somatropin injection is used for the treatment of growth hormone deficiency in children as well as growth disruption caused by Turner’s syndrome or chronic renal insufficiency, the company said. The drug is being offered as an alternative to Pfizer’s Genotropin.

“Together with our parent company Novartis, we are fully committed to broadening access to innovative and affordable biopharmaceuticals over the years and decades to come, both in Japan and worldwide,” said Jeff George, Chief Executive of Sandoz.

The approval marks the first-ever biosimilar drug to be approved in Japan.

Stefan Borgas, chief executive of drug supplier Lonza Group Ltd, told Reuters that he expects biotech drugs to become a “significant market.”

“I think common wisdom at the moment is that the global biologics market is something like $80-90 billion, and what the price reduction will be is a bit of a crystal ball discussion at the moment,” he said.

“Even if the most optimistic forecast is too optimistic, it will be a significant market. In the billions and the 10s of billions.”

Sandoz said that by 2010, about 50 percent of newly approved medicines would be biopharmaceuticals, as an increasing number of major biotechnology-based medicines come off patent and face generic competition.

“Biosimilars are an integral part of the Sandoz strategy to focus on difficult-to-make products that provide added patient benefits,” the company said in a statement. “Due to the rising costs of health care and the growing need for more complex treatments, they will play an increasingly important role in ensuring and broadening global access to medicines.”

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