Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago.
A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.
Drug maker Keryx Biopharmaceuticals got promising results from a late-stage clinical trial of a drug for treating elevated phosphate levels, also known as hyperphosphatemia, in patients on kidney dialysis, the company said Tuesday.