A top executive at Epirus Biopharmaceuticals says it was the crash in biotech stocks over the past year that was behind the decision this week to switch from developing generic versions of big, widely-used biologic drugs to focus on those aimed at much smaller rare diseases.
The change of focus for Epirus (Nasdaq: EPRS) comes amid a fierce debate among drugmakers around the relatively new field of so-called biosimilars, which differ from regular generics in that they are made through biologic, rather than chemical, means and therefore can’t be exact copies. The Food and Drug Administration only came out with guidelines on how it will approve such drugs in the past couple years, and some drugmakers want the agency to set a high bar for any copy of a biologic to be considered “interchangeable” with the original. Generic drugmakers argue for a lower bar, saying that biosimilars would help bring down high drug costs.
The change of focus for Epirus (Nasdaq: EPRS) comes amid a fierce debate among drugmakers around the relatively new field of so-called biosimilars, which differ from regular generics in that they are made through biologic, rather than chemical, means and therefore can’t be exact copies. The Food and Drug Administration only came out with guidelines on how it will approve such drugs in the past couple years, and some drugmakers want the agency to set a high bar for any copy of a biologic to be considered “interchangeable” with the original. Generic drugmakers argue for a lower bar, saying that biosimilars would help bring down high drug costs.
