Novartis generics firm gets “breakthrough” drug approval

Novartis’ generics arm, Sandoz, has received approval from the FDA for Omnitrope, a human growth hormone.

The company describes this as a “breakthrough” as it is the first follow-on version of a formerly patented recombinant drug in the US.

Recombinant technology utilises the conjunction of DNA fragments to create an artificial DNA sequence that can be used to create insulin, growth hormones and vaccines. Omnitrope is now licensed to treat growth disorders in adults and children in the US, EU and Australia.

Dr Andreas Rummelt, chief executive officer of Sandoz, remarked: “The FDA’s approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for health care providers and patients worldwide.”

“The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the US,” he added.

Omnitrope is already on sale in Germany following European Commission approval on April 19th.

Sandoz says it believes that all recombinant drugs should be approved for generic manufacture following the expiry of patents to afford a better deal for patients and healthcare providers.

In 2004, the FDA deferred the decision to approve Omnitrope on scientific and legal grounds, even if the data said the drug was safe for use. The FDA said there was “uncertainty” surrounding the first two issues.

Last year Sandoz acquired Hexal and Eon Labs to help make the company become more technologically advance and increasingly able to make “difficult” generic drugs like inhaled products or transdermal patches.

© Adfero Ltd