SAN FRANCISCO — After a decade of work and tens of millions in spending, Sandoz fears its debut of a drug for the skin condition psoriasis will be met with a crippling patent infringement suit.
Sandoz has high hopes for its drug, which could be one of the first biosimilars to reach the U.S. market. But U.S. District Judge Maxine Chesney ruled this week that the company cannot ward off a patent offensive from the market leader, Amgen, until it has a bona fide drug to protect. Sandoz has not yet filed an application with the Food and Drug Administration, much less received the stamp of approval it will need to bring its drug to patients.
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