Drugs' expiring patents loom

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No topic is of greater importance in the biotechnology industry than the fate of off-patent biological drugs when generic competition becomes legal.

A new report from Decision Resources predicts the world's largest manufacturers of biological drugs — Amgen and Genentech, both based in California — should brace for lower sales for their blockbuster drugs by 2012.

In that year, the top biological drug could be in for its first encounter with a generic rival as versions of biological drugs used to treat arthritis and inflammatory conditions will be debuted. These generic drugs will encroach on the market share for the world's top-selling biologic — Enbrel.

The report forecasts that the market for biogeneric versions of 13 key biological brands in the United States and the five major European marketswill reach nearly $3.4 billion in 2016, reducing the branded sales of these agents by $10 billion compared with sales in 2006.

"This growth in the U.S. biogeneric market will be driven by biogeneric TNF-alpha inhibitors for rheumatoid arthritis, which we project will generate $700 million in sales by 2016, and will be supported by biogeneric versions of interferon-betas for multiple sclerosis, Herceptin for breast cancer, and ESPs for chemotherapy-induced anemia, each of which will post more than $250 million in 2016 U.S. sales," said Andrew Merseth, an analyst at Decision Resources.

Genentech drugs such as Rituxan/MabThera (rituximab) and Herceptin (trastuzumab) represent windfall opportunities for biogeneric manufacturers, the report found. Global sales of the two blockbusters were more than $7 billion last year.

But the company's findings, which also show oncologists are ready to prescribe generic versions of biological drugs, could be moot if Congress does not create an approval process for biogenerics. These generics are already a reality in Europe, but lawmakers are skeptical there is enough time to pass a bill this year that opens the door for biogenerics.

A win for Amgen

Meanwhile, in other drug-related news, a Food and Drug Administration panel rejected a proposal to set a specific limit for the red blood cell levels in patients with kidney disease.

The decision is a major boost for Amgen, the biotech giant in California, which has been struggling with regulatory issues over the past year. Amgen makes Epogen and Aranesp, which boost the number of red blood cells. A lower blood-level count would have dealt a blow to the sale of the drugs.

Studies showed health risks associated with the drugs, prompting the FDA to strengthen warning labels Epogen and Aranesp to warn doctors that when used in doses larger than recommended, the drugs can increase the risk of developing blood clots, heart attacks and strokes in patients with chronic kidney failure.

There is little consensus about the safety of the drugs. Medicare has already lowered the drugs' dosage level that it will reimburse doctors. At this point, the only restrictive action the FDA could take is to put a red blood cell level target number on the label. Amgen would prefer if the FDA do that, the target level be set at 10 to 12 grams per deciliter. But critics of the medications say doctors shouldn't prescribe doses over 11 grams for either drug.

• Health Care runs on Fridays. Contact Gregory Lopes at 202/636-4892 or glopes@washingtontimes.com