Sandoz takes issue with FDA over biogenerics

By Phil Taylor

- Last updated on GMT

Related tags Fda Food and drug administration

Sandoz, the generic drug unit of Swiss pharmaceutical group
Novartis, has filed a law suit against the US Food and Drug
Administration (FDA) alleging that the agency is dragging its feet
in a review of a 'biogeneric' drug filed by the company.

Sandoz is calling for a swift ruling on its pending application to market its human growth hormone product Omnitrope, based on an abbreviated approval route that does not require the conduct of extensive clinical trials.

In the US, this type of product is known as a "follow-on" biologic, while in Europe the preferred term is 'biosimilar'. The FDA in particular has been struggling to work out a suitable regulatory route to market for this type of product, which could cut the cost of treatment with biologic drugs. Many of these agents have lost or are near losing patent protection, but their originators remain safe from generic competition, allowing prices to remain high, in some cases tens of thousands of dollars per patient per year.

In Europe, a revamp of the legislation surrounding pharmaceuticals last year spears to have cleared a review process for biosimilars, and the first applications are already under review at the European Medicines Agency (EMEA).

Sandoz filed its NDA for Omnitrope in July 2003 but, in September of the same year, the company said it had been told by the FDA that the agency was unable to reach a decision on whether to approve the application, citing scientific and legal issues No action on the application has been taken since then, it says.

Under the terms of both the federal Food, Drug & Cosmetic Act and the Prescription Drug User Fee Act, the agency is required to either approve or reject NDAs, says Sandoz, adding that its lawsuit, which was filed in US District Court for the District of Columbia, seeks to reverse the agency's failure to act on the Omnitrope application 'in accordance with the FDA Commissioner's statutory obligations'.

The agency lacked any basis in fact or law upon which to deny approval, according to the suit, which claims FDA staff had informed Sandoz that Omnitrope was safe and effective for its intended use and that it was indistinguishable from the originator product, Pfizer's Genotropin. On 13 May, 2004, Pfizer filed a Citizen Petition with the FDA, calling on it to reject Omnitrope's application.

"We believe it is important for patients and health care providers that cost-effective follow-on protein products like Omnitrope become available as safe and effective, but less expensive, and equivalent therapeutic alternatives,"​ said Sandoz chief executive Andreas Rummelt.

"Having already acknowledged the sound science behind this application, the FDA should approve Omnitrope,"​ he added.

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