Sandoz Introduces New Follow-On Version of Recombinant Biotechnology Drug

ePT--the Electronic Newsletter of Pharmaceutical Technology

Sandoz introduced its "Omnitrope Pen 5" with liquid cartridge in the United States. The product was approved by the US Food and Drug Administration and is a new form of the first follow-on version of a recombinant biotechnology drug.

Princeton, NJ (Mar. 12)-Sandoz introduced its “Omnitrope Pen 5” with liquid cartridge in the United States. The product was approved by the US Food and Drug Administration and is a new form of the first follow-on version of a recombinant biotechnology drug.

The new delivery system contains dissolved liquid in a ready-to-use cartridge, thus providing convenience for patients. The liquid can be loaded into the pen for injection. The Omnitrope Pen 5 is available in 5-mg strength.

According to FDA, Omnitrope has highly similar pharmacokinetic, pharmacodynamic, safety, and efficacy profiles to those of Pfizer’s (New York) “Genotropin” drug. The same comparability standard currently is applied to brand products made by recently modified manufacturing processes.

In a company press release, Bernhard Hampl, CEO of Sandoz’s US subsidiary, said the new product “represents Sandoz’s commitment to meeting the needs of patients through providing more convenient delivery systems.”

An Omnitrope liquid-pen system has been available in Europe since spring 2007. FDA approved a lyophilized powder form of Omnitrope in May 2006 under the Hatch–Waxman Act. Sandoz introduced the drug in the US in Jan. 2007.

Omnitrope was the first biosimilar to be approved in Europe, and no other follow-on biologic has been approved and made available to patients in both regions, according to the company.

Omnitrope, a somatropin (rDNA origin) for injection recombinant, is approved for the long-term treatment of pediatric patients with growth failure and for long-term replacement therapy in adults with growth-hormone deficiency.