Sandoz has received US Food and Drug Administration approval for its Omnitrope Pen 10 with liquid cartridge. Omnitrope, a somatropin, is approved for long-term treatment of paediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.

There are approximately 50,000 paediatric patients and 25,000 adult patients who use a somatropin in the US. The Omnitrope Pen 10 with liquid cartridge provides increased treatment flexibility for physicians and a more convenient dosage form for patients. It will also offer significant cost savings compared to the reference product, Genotropin, and other leading recombinant growth hormones.

"The FDA approval of the 10 mg strength of Omnitrope will allow physicians to treat a broader spectrum of patients with a high quality, lower cost treatment option," said Bernhard Hampl, chief executive officer of Sandoz Inc, the US subsidiary of Sandoz. "Follow-on biologics are a key part of the Sandoz strategy and we are committed to increasing patient access through follow-on biologics once patents have expired."

The 10 mg version has been marketed by Sandoz in key European countries since earlier this year. A 5 mg strength version, Omnitrope Pen 5 with liquid cartridge, has been available in the US since March.

Omnitrope is highly similar to Genotropin in its safety and efficacy profiles. Sandoz pioneered the field of follow-on biologics with the approvals and subsequent launches of a lyophilized powder form of Omnitrope in the US and Europe. Omnitrope was the first follow-on biologic to receive approval and be made available to patients in both regions. It was the first ever medicine to be approved in the EU as a biosimilar, the European regulatory term for such products.

Follow-on biologics are a key part of the Sandoz strategy to focus on difficult-to-make generics that provide added patient benefits. 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 access to medicines. Sandoz is building a strong global pipeline of follow-on biologics, with 25 projects currently under development.

Sandoz, a division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents.