Biotech Drugs Get Seven Year Protection
July 14th, 2009 by admin
Terming it a “generous compromise” amongst plans set out by strong California Democratic U.S. representatives Henry Waxman and Anna Eshoo, the Obama administration stated that biogeneric drugs should be guarded from competition for seven years. The biopharmaceutical industry has argued that the five years of guarding given by Waxman in H.R. 1427 would stifle innovation. But the Federal Trade Commission in a report earlier this month stated the 12 to 14 years that the industry has said publicly that it needs also would hurt innovation and delay patients’ access to cheaper drugs.
Eshoo’s H.R. 1548 calls for a 12-year period of data exclusivity, basically guarding the patents covering innovative biotech therapies. “We believe this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines and cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS as well as unmet medical needs,” BIO President and CEO Jim Greenwood issued in a statement. Biogenerics definitely has a huge potential as cost containment is on the rise world over. With the Medicare Modernization Act being passed in the U.S., pricing will be an important discriminating factor world over.
In a letter to Waxman, Nancy-Ann DeParle, Obama’s health-care reform director, and budget director Peter Orszag announced “the seven-year policy in the FY 2010 Budget is a generous compromise amidst what the FTC research has concluded and what the pharmaceutical industry has advocated. ”The Biotechnology Industry Organization, however, stated it is “extremely concerned” that the seven-year plan is “a risky shortcut to biosimilars.”
Biogenerics is the new buzzword in the biotech industry and is all set to create a revolution in the next couple of years. Biotech companies are hoping to reap the same levels of success as the large pharma generic players. Many of the patented biopharmaceuticals are going off patent in 2009 itself, paving way for the boom in the biogenerics market. Biogenerics are likely to expand the usage of biotech based medications in a big way as the high prices of the original biotech drugs restricted their reach even in emergency care like cancer and renal failures.
U.S. and Europe are the leaders in this biogenerics followed by Asia. India stands out as one of the largest players followed by countries such as China, Japan, Korea and Taiwan. The expected world market for biogenerics is estimated to be $2 billion in 2008.
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