Biotech Values

[DewDiligence]

More on the Omnitrope story:
Not surprisingly, the GPhA
trade group agrees with NVS
(and not with the FDA) that the
Omnitrope decision is a
significant precedent.

http://biz.yahoo.com/prnews/060531/nyw111.html?.v=58

>>
GPhA Hails Omnitrope Approval as Significant First Step in Opening Door to Biopharmaceutical Savings for U.S. Consumers

Source: The Generic Pharmaceutical Association

Says Decision Demonstrates that Pathway Exists for Approvals

ARLINGTON, Va., May 31 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today called the approval by the U.S. Food and Drug Administration (FDA) of Sandoz's Omnitrope Human Growth Hormone (HGH) a significant first step in bringing more affordable biopharmaceuticals to the U.S. marketplace.

"FDA's Omnitrope decision clearly demonstrates that sound science exists to support the approval of generic biopharmaceuticals despite assertions from special interests to the contrary," said GPhA President and CEO Kathleen Jaeger. "Although it is our position that the 505(b)2 FDCA approval process, in conjunction with FDA's authority under the Public Health Act (PHS), already serves as a foundation for the approval of safe and effective generic biopharmaceuticals, we will continue to call on Congress to codify FDA's authority to approve generic biopharmaceuticals under section 351 of PHS. It is critical, with approvals coming regularly in Europe and around the world, that American consumers are not left behind in having timely access to safe, effective and affordable generic versions of brand biopharmaceutical products."

Jaeger added that the approval demonstrates that U.S. generic companies have highly sophisticated research and development capabilities and are ready to enter the U.S. biopharmaceutical market. While many biopharmaceuticals are already off-patent, more than $10 billion worth of biopharmaceutical drugs are expected to come off patent over the next five years. Many of these drugs cost more than $10,000 each year, expenditures that many consumers, businesses, insurers and private and public health care providers find unacceptable and unaffordable.

"The approval of this product represents a significant first step toward opening the door for billions of dollars in potential savings on biopharmaceutical products for American consumers," Jaeger said. "It demonstrates that generic companies can develop safe and effective biopharmaceutical products. It demonstrates that FDA already has the authority to approve such products. And it brings our nation one step closer to the day when generic versions of expensive biopharmaceuticals will be readily available, as they already are in Europe and around the world, to help dramatically lower America's health care costs."

Biopharmaceuticals are generally large protein molecules derived from living cells, (such as antibiotics, insulin and human growth hormone). While the United States has been debating the manufacture of generic biopharmaceuticals, citizens of other nations are already enjoying access to more affordable generic biopharmaceutical products.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 53% of the total prescriptions dispensed in the United States, but only 12% of all dollars spent on prescription drugs.
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