Omnitrope Victory Narrows FDA's Options On Biogenerics

By Ramsey Baghdadi

A federal court decision in favor of Novartis AG's Sandoz unit for its follow-on human growth hormone somatropin (Omnitrope) gives the US Food and Drug Administration one less delay tactic in the debate over an abbreviated pathway for biogenerics.

The US District Court for Washington, D.C. granted Sandoz summary judgement on the Omnitrope application, which was filed in July 2003, essentially mandating that FDA make a regulatory decision on the application.

The decision is a clear-cut loss for FDA, according to Steven Irizarry, VP-government affairs with ML Strategies. "The tone of the memorandum is very important," Irizarry said of District Court Judge Ricardo Urbina's decision memorandum. "The court is going to be very wary and look with a scrupulous eye at what FDA does."

But the issue is far from resolved. In fact, the court decision alone is not enough to force FDA to make a "yes or no" answer on a regulatory route for follow-on biologics in general--or even for Sandoz' application in particular. FDA will most certainly appeal the ruling. The agency could also take a regulatory action without making a final decision by issuing a "non-approvable" letter or an "approvable" letter, which is less harsh, but can turn out to be practically equivalent. For example, Bristol-Myers Squibb's diabetes drug muraglitazar (Pargluva) was deemed "approvable" but Bristol and its marketing partner Merck chose to scrap the program altogether rather than going down the road of collecting more clinical data.

Still, the court victory is exactly what proponents of follow-on biologics wanted. The ruling puts the ball squarely in FDA's court and forces them to make a move that will undoubtedly be harshly dissected in the public domain, no matter which direction the agency chooses to go in.

FDA has revealed its cards regarding the course the agency will take on the regulatory front. In a March 17 letter, FDA associate commissioner for legislation Patrick Ronan said the agency would not issue product-specific guidance and, instead, would create guidance "more broadly applicable" to follow-on protein products (FOPPs). Ronan's letter was in response to a February 10 letter co-authored by Utah Republican Senator Orrin Hatch and Democratic California Congressman Henry Waxman asking for biogenerics guidance on insulin products and human growth hormone, specifically.

Of course, a more general guidance-or "white paper"-will take considerably longer than documents focused more specifically on product categories. Companies interested in pursuing FOPPs will have to continue using a strategy of "incrementalism" while FDA delays an abbreviated pathway indefinitely(See "Biogenerics Are Happening," The RPM Report, January 2006).

The most likely outcome is an appeal by FDA and the subsequent release of a legal backgrounder on all biologics approvals up to the present. That kind of move would delay another decision on the legal front and somewhat appease the growing calls for action by the agency. One interesting option at FDA's disposal is to issue a notice asking for a hearing with Sandoz. Within 30 days, Sandoz would choose to either accept or reject the request. If they accept, that would start another 180 day clock, which would delay a decision by at least another 210 days. Sandoz would almost certainly deny any request for a hearing. The Novartis unit's next step will likely be to file a motion for a decision on the Omnitrope application within a specified short period of time.

But don't expect a white paper on follow-on biogenerics anytime soon. FDA remains in the driver's seat until Congress decides to step up it's interest on the matter. And piquing the interest of key lawmakers on Capitol Hill in an election year will be a tough sell.

Comments? E-mail the author at rbaghdadi@windhover.com