Novartis division Sandoz gets first biotech generic approval

Sandoz, a division of Novartis, has received the first ever European approval for a generic version of a biotech drug, or ‘biosimilar’.

The firm has received the positive opinion from European Medicines Agency?s (EMEA) Committee on Medicinal Products for Human Use (CHMP) regarding the company?s recombinant human growth hormone Omnitrope.

Sandoz chief executive Dr Andreas Rummelt said: “The positive CHMP opinion for Omnitrope is an important step on the way to make this medicine available for patients who need it.

“Omnitrope will contribute to cost savings in the health care systems and we are confident that the European Commission will now grant marketing authorisation.”

In 2003 Omnitrope was turned down by the commission on legal grounds, but recent changes have provided a pathway for biosimilars.

The product has already received clearance in Australia and it is hoped following the European decision the US Food and Drug Administration (FDA) will follow suit.

Dr Rummelt added: “With Omnitrope’s positive status in Europe, we now hope the FDA will finally move in granting a marketing authorization for the US, acknowledging the sound science that supports this product.

“We are determined to make high-quality and cost-effective biosimilar products like Omnitrope available for patients and healthcare providers worldwide.”

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