In­ter­change­abil­i­ty with­out switch­ing stud­ies: FDA ex­plains why a new Lu­cen­tis biosim­i­lar may be a game-chang­er

Of the near­ly 40 biosim­i­lars ap­proved to date by the FDA, on­ly three have won the cov­et­ed in­ter­change­abil­i­ty des­ig­na­tion so far, mean­ing that like small-mol­e­cule gener­ic drugs, they can be  sub­sti­tut­ed at the phar­ma­cy counter with­out the in­ter­ven­tion of the pre­scriber.

In­ter­change­able biosim­i­lars have been lim­it­ed so far, as the FDA has made clear that in or­der to ob­tain this des­ig­na­tion, spon­sors have to meet ad­di­tion­al re­quire­ments that oth­er biosim­i­lars don’t have to meet, in­clud­ing so-called switch­ing stud­ies where spon­sors show that the risk of di­min­ished ef­fi­ca­cy or safe­ty from switch­ing be­tween a biosim­i­lar and its ref­er­ence prod­uct “is not greater than the risk of us­ing the ref­er­ence prod­uct with­out such al­ter­na­tion or switch.”

Endpoints News

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.