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.

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