FDA is ready to eliminate the interchangeability designation for biosimilars
As part of efforts to level the playing field between biologics and biosimilars, the FDA is calling on Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion.
When it was established in 2010, the interchangeability designation was meant to delineate between which biosimilars could be switched automatically at the pharmacy counter without a doctor’s recommendation. But since then it has caused inaccurate perceptions and no longer makes scientific sense, the agency said.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
