Novartis' legal challenge over FDA inaction on its Omnitrope NDA could set the stage for a court ruling on whether the 505(b)(2) pathway can be used for approval of a "follow-on" biologic.

In a lawsuit filed Sept. 13 in D.C. federal court, Novartis' generic division Sandoz seeks a declaratory judgment that the 505(b)(2) pathway "can be used for protein-based biologic drugs regulated under Section 505 of the FD&C Act."

Sandoz also seeks an order compelling FDA "to issue the statutorily required action letter" on the Omnitrope NDA.

The lawsuit alleges that the agency has violated the FD&C Act and Administrative Procedure Act by failing to act on Sandoz' NDA for the recombinant human growth hormone product in a timely fashion.

Sandoz filed the Omnitrope (somatropin) NDA on July 30, 2003 under section 505(b)(2) "after extensive discussion with FDA's professional scientists and reviewers in the reviewing division responsible for approving metabolic and endocrine drug products like Omnitrope," the complaint states.

The filing was based on Sandoz' preclinical, clinical and comparability testing; literature references; and "FDA's prior determination on the public record of the safety and efficacy" of the reference listed drug, Pfizer's Genotropin (somatropin), the complaint says.

The user fee deadline for the Omnitrope application was extended by three months due to a major chemistry amendment; the extended user fee deadline was August 31, 2004.

The NDA for Omnitrope has largely been seen as a "test case" at the agency for approval of follow-on biologics under the 505(b)(2) pathway. However, FDA appears to be waiting for further clarification of issues surrounding generic biologics.

In September 2004, Sandoz announced that FDA was unable to reach a regulatory decision on Omnitrope due to uncertainty regarding scientific and legal issues relating to follow-on proteins (¹ Also see "FDA Makes It Official: Action On Human Growth Hormone Will Wait" - Pink Sheet, 2 September, 2004.).

"One year after the August 31, 2004 extended PDUFA date, the defendants have yet to act upon the Omnitrope application by issuing as required under the FD&C Act and the user fee statutes a complete action letter either approving the product, or detailing specific deficiencies and any actions necessary to clear the way for an approval," the complaint states.

"There has been no substantive correspondence from the defendants to Sandoz relating to NDA 21-426 since Aug. 31, 2004, despite Sandoz' two resubmissions and renewed requests for approval of its application."

Sandoz says it has exhausted all available administrative remedies through FDA.

"The defendants' actions on and failure to approve the Omnitrope NDA constitute final agency action," the complaint alleges. "It is futile for Sandoz to seek any further administrative relief, and any new or further administrative proceedings before the agency also would be futile, as the defendants have confirmed as recently as Sept. 12, 2005 that no timetable will be given by or for FDA to act on the Omnitrope NDA."

Sandoz also asserts that agency inaction on Omnitrope constitutes "constructive granting" of Pfizer's May 2004 citizen petition, which requested that FDA deny approval of Sandoz' 505(b)(2) application (² Also see "Pfizer Petitions FDA To Deny Sandoz Omnitrope NDA; Test Case For Follow-On Biologics" - Pink Sheet, 1 June, 2004.).

FDA is working on a white paper on the historical development of biologics approval policy, as the first in a series of documents on follow-on proteins (³ Also see "FDA Follow-on Proteins Draft Guidance Will Be Followed By Third Public Meeting" - Pink Sheet, 14 February, 2005.).

However, release of those documents has been repeatedly delayed (⁴ Also see "Follow-On Biologics White Paper From FDA Could Be Delayed Until Fall" - Pink Sheet, 2 August, 2005.).

- Sue Sutter

Sandoz Sues FDA For Inaction On Omnitrope NDA

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