Biotech Values

[DewDiligence]

Major story: FDA Approves NVS’ rhGH under Section 505b2

[Although drugs approved under Section 505b2 are not true generics because they are not substitutable at will for a branded reference drug, the FDA’s approval of NVS’ Omnitrope is nevertheless a significant milestone in that it’s the FDA’s first approval of a copycat drug made using recombinant technology.

NVS’ application had been languishing at the FDA for almost three years! NVS got tired of waiting, sued the FDA in federal court (#msg-7723132), and won: the court ordered the FDA to fish or cut bait, and now the Agency has reluctantly decided to fish.]

http://online.wsj.com/article/SB114904669181067236.html

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By ANNA WILDE MATHEWS
May 31, 2006 12:05 a.m.

The Food and Drug Administration approved a copycat version of human growth hormone made by a unit of Novartis AG, a closely watched decision amid debate over how to move toward generic biotechnology drugs.

The approval of Sandoz's Omnitrope, which became public late Tuesday night through a posting on the FDA's Web site, is important because it confirms that the FDA has the scientific knowledge to approve a so-called "follow-on" version of at least a simple biotechnology drug. Sandoz has said its product is similar to Pfizer Inc.'s Genotropin, and Pfizer filed a petition opposing approval of Omnitrope.

Still, the agency didn't rate Omnitrope as equivalent to Genotropin, as it does with generic versions of traditional chemically derived drugs. [I.e. Omnitrope is not automatically substitutable for Genotropin and hence a prescription must explicitly specify Omnitrope in order for a patient to end up with Omnitrope.] A spokeswoman for Sandoz declined comment.

The FDA downplayed the decision in the document posted on its Web site, saying it "does not establish a pathway" for approval of other follow-on biotech drugs. The agency has said that Congress must change the law before it can approve any copies of nearly all other biotech products, and lawmakers haven't moved on the issue.

For historic reasons, a handful of biologic products, including human growth hormone and insulin, are regulated differently than the rest and do not require a change in the law for FDA to approve follow-on versions. "This was reviewed under a part of the statute that allows for approval of a follow-on protein but the FDA doesn't have the legal authority or a pathway to approve a generic biologic," an agency official said late Tuesday night.

In addition, the FDA official said that Sandoz "did not rely on proprietary information contained in the Genotropin application." He said Sandoz used publicly available information about the Pfizer product, along with its own studies, to demonstrate that Omnitrope was safe and effective.

That was a key question raised by Pfizer, which argued that Sandoz could not rely on nonpublic findings about Genotropin to win approval for Omnitrope. Other biotech companies have also objected to the idea of generics makers relying on data in their applications to win approval for copies.

The agency also noted in its posting that it has approved follow-on versions of other drugs derived from biologic sources. But Omnitrope appears to represent the first time the agency has approved a copycat version of a true "recombinant" biotech drug, or one grown by the manufacturer in living cell lines. Generic biotech drugs are a prospect eagerly sought by generics makers and opposed by much of the biotech industry, which hasn't had to face competition from lower-priced copies even as its products have become some of the most important and expensive medicines. Omnitrope became a significant skirmish in the broader lobbying battle over the issue.

Sandoz, which originally filed its application in July 2003, sued the FDA over its delay of a decision on the product, winning an April ruling from a federal judge that the agency must give an answer. The approval is a win for the aggressive approach taken by Sandoz. Omnitrope had already won approval from European and Australian regulators.

In the U.S., several human growth hormone products are already on the market, made by companies including Eli Lilly & Co. and Genentech Inc., but according to industry officials, each of those drugs had to be approved independently as a full new application.

The question of what studies generics makers have to do in order to sell new versions of biotech drugs is at the heart of the conflict between the generics and biotech industries. Traditional chemically based drugs are easier to duplicate than biotech medicines. Making the active ingredients typically involves well-understood chemical processes. Biotech medicines, by contrast, are generally produced by splicing a genetic sequence that corresponds to a particular protein, such as human insulin, into living cells. The proteins in biologic medicines are much larger and less well-understood than traditional "small-molecule" drugs.

Biotech makers have sometimes argued that because their products are so complicated to make, and the process is proprietary, a generics maker would essentially have to test a copy with all the same costly trials that led to approval of the original – thus removing the price advantage of a generic. For their part, generics companies say that they can manufacture safe, effective versions of existing biotech drugs without duplicating all of the original research.
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