T Nation

Omnitrope: New Generic GH

Word through the grapevine just told me that Novartis’ new generic GH product “Omnitrope” was just approved. It’s a 191aa GH product, but more cheap than the others currently available.

Look for this to be available on the BlackMarket soon.

Generic Biotech Drug OK Rekindles Debate
Wednesday, May 31, 2006 8:16 PM EDT
The Associated Press

SAN FRANCISCO (AP) - The approval of the generic form of a biotechnology drug rekindled fierce debate within the pharmaceutical industry and Washington over how federal regulators should handle similar applications as patents expire on billions of dollars worth of drugs.

The high cost of biotechnology medicines - some fetch more than $100,000 annually per patient ? have made them an attractive target for generic manufacturers. But Food and Drug Administration officials say they don’t have the authority to approve biotech knockoffs and insisted its approval Tuesday was of a “follow-on protein product” rather than a generic drug."

Further, the FDA said on its Web site that its approval of the medicine for children with growth disorders Tuesday night “does not establish a pathway for approval” and said Congress needs to pass legislation to give the agency such authority.

Still, generic proponents said the FDA’s action opened the door to generic competition in the biotechnology industry, which is expected to have $60 billion in annual drug sales by 2010.

“This is clearly a model for gaining approval of generic biologics,” said Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association. “FDA has finally acknowledged that science supports the approval of biologic generics.”

Jaeger said the association is working with lawmakers to introduce legislation specifically authorizing FDA to approve biotech generics. Similar proposed legislation has stalled previously.

The newly approved drug called Omnitrope made by Novartis A.G.'s generics subsidiary Sandoz is a knock off of the drug Genotropin made by Pfizer Inc., which opposed the application. Analysts expect Omnitrope to be offered about 25 percent cheaper than Genotropin and win a large portion of Pfizer’s annual sales of $808 million human growth hormone.

“We are reviewing FDA’s actions to determine if further action is warranted or appropriate,” Pfizer said in a statement. “We believe it would be scientifically and legally improper for FDA to rely on clinical and manufacturing information for Genotropin as a basis for approving Sandoz’s somatropin product (Omnitrope).”

The lobbying outfit Biotechnology Industry Organization has argued for more stringent, lengthy and expensive testing of generic biologic drugs than traditional medicines. BIO said Wednesday it doesn’t comment on specific product approvals but affirmed it call for more extensive human testing of generic biotechnology medicines.

“Unlike traditional drugs, biologics are complex substances produced using living organisms,” said BIO chief executive Jim Greenwood.

The Pharmaceutical Research and Manufacturers of America, which represents drug companies, said it’s reviewing the FDA’s decision.

Most biotechnology drugs are newer and more complex to make than traditional medicines. The FDA is precluded from approving generic versions of biotech drugs by the same law that enabled it to swiftly approve generic versions of traditional pharmaceutical medicines.

At the heart of the conflict is sharp disagreement over how to determine generic biotech drugs are as safe and effective as their brand-name counterparts. Biotechnology drugs are typically made in living cells through genetic engineering, making it near impossible to make exact generic copies of living things. Traditional pharmaceuticals, on the other hand, are made from off-the-shelf chemicals and are easily reproduced generically.

Generic drug makers have to simply show the FDA that their pills are equivalent to their brand-name counterparts. The biotechnology industry argues that generic manufacturers should be required to conduct lengthy and costly human tests of its drugs before getting approval.

A federal judge in April ordered the FDA to promptly act on Sandoz’ application after the company filed a lawsuit demanding action on its application. Now that it has won, the company said generic biotechnology drugs in the United States will be key growth driver for Sandoz.

“The approval of Omnitrope is a major step forward in brining needed clarity to the approval process for follow-on biotechnology medicines in the U.S.,” Sandoz chief executive Andreas Rummelt said.

thank you