Novartis gains approval for first Japanese biosimilar
pharmafile | June 25, 2009 | News story | Research and Development, Sales and Marketing |Â Â Novartis, genericsÂ
Japan has approved its first biosimilar medicine – the recombinant human growth hormone somatropin from Novartis' generic arm Sandoz.
The company, which launched the same product as Europe's first biosimilar three years ago, says the new decision will reinforce its reputation as a global leader in the emerging market.
Sandoz chief executive Jeff George added: "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."
Biosimilars are generic substitutable versions of branded biologic drugs, which looks to be a growing market as many healthcare systems cutback on costs.
They are similar to original branded drugs but, due to the complex nature of biotechnology medicines, they are not identical, which has produced some technical, regulatory and legal obstacles for companies.
But the market for biosimilar drugs is potentially worth billions, and the persistence of Sandoz has paid off.
Japan regulators approved its somatropin to treat growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency – the same range of indications covered by the branded product Genotropin, marketed by Pfizer in Europe.
Sandoz's biosimilar won European approval 2006 under the name Omnitrope, and the latest authorisation comes just three months after Japanese authorities published guidelines to pave the way for a national biosimilar regulatory pathway, based on similar scientific principles to those in the EU.
It is approved on the basis that it offers patients comparable quality, safety and efficacy to the reference product Genotropin.
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