Bi­par­ti­san group of sen­a­tors seeks to elim­i­nate in­ter­change­abil­i­ty des­ig­na­tion for biosim­i­lars

The US biosim­i­lar mar­ket has al­ways been dis­tinct from the EU mar­ket, par­tic­u­lar­ly when it comes to the des­ig­na­tion of cer­tain biosim­i­lars as be­ing in­ter­change­able or al­lowed to be switched at the phar­ma­cy counter for their brand name coun­ter­parts with­out a physi­cian’s in­ter­ven­tion.

On­ly a small hand­ful of com­pa­nies have won this des­ig­na­tion so far in the US, where­as all biosim­i­lars are deemed in­ter­change­able in the EU. Now, a group of bi­par­ti­san sen­a­tors is look­ing to align the US and EU fur­ther, and elim­i­nate the in­ter­change­abil­i­ty des­ig­na­tion in the US.

“Our cur­rent reg­u­la­to­ry en­vi­ron­ment im­pos­es oner­ous and cost­ly bur­dens that hin­der the en­try of biosim­i­lars in­to the mar­ket. Ul­ti­mate­ly, it’s the pa­tients who bear the brunt of lim­it­ed com­pe­ti­tion and ex­or­bi­tant drug prices. We owe it to them to break down these bar­ri­ers and en­sure they have time­ly ac­cess to these life-chang­ing drugs,” co-spon­sor Sen. Mike Lee (R-UT) said in a state­ment. Sens. Ben Ray Lu­ján (D-NM), Mike Braun (R-IN) and JD Vance (R-OH) are al­so co-spon­sors.

Both PBMs and the bio­phar­ma in­dus­try-backed Biosim­i­lars Fo­rum have ex­pressed in­ter­est in see­ing the in­ter­change­abil­i­ty des­ig­na­tion re­voked.

“The Biosim­i­lar Red Tape Elim­i­na­tion Act will make it eas­i­er to re­al­ize these pro­ject­ed sav­ings. By deem­ing all biosim­i­lars as in­ter­change­able up­on FDA ap­proval, this im­por­tant leg­is­la­tion would make it eas­i­er, de­pend­ing on state law, for phar­ma­cists to sub­sti­tute biosim­i­lars for brand prod­ucts thus re­mov­ing an im­por­tant bar­ri­er to biosim­i­lar up­take,” PBM Prime Ther­a­peu­tics said, back­ing the bill. “This move would re­duce com­plex­i­ty for phar­ma­cies, pre­scribers, and pa­tients, there­by re­duc­ing bar­ri­ers to biosim­i­lar dis­pens­ing.”

Biosim­i­lars Fo­rum ex­ec­u­tive di­rec­tor Ju­liana Reed sim­i­lar­ly told End­points News in an in­ter­view last week that Con­gress should reeval­u­ate whether the in­ter­change­abil­i­ty des­ig­na­tion for biosim­i­lars “is still nec­es­sary.”

Most re­cent­ly, the FDA has re­laxed some of its rules around when it might re­quire so-called switch­ing stud­ies, where pa­tients al­ter­nate be­tween the ref­er­ence prod­uct and the in­ter­change­able biosim­i­lar and com­pare those to oth­ers just on the ref­er­ence prod­uct, to earn an in­ter­change­abil­i­ty des­ig­na­tion.

“To­day, it is abun­dant­ly clear that switch­ing stud­ies are un­nec­es­sary,” Sen. Lee wrote in a re­port re­lat­ed to the bill. “The Eu­ro­pean Med­i­cines Agency (EMA) has been ap­prov­ing biosim­i­lars since 2006. In 2022, af­ter an­a­lyz­ing more than fif­teen years of da­ta, the EMA stat­ed that there is no ev­i­dence that switch­ing be­tween a biosim­i­lar and its ref­er­ence prod­uct in­creas­es the risk of im­muno­genic­i­ty.”

But Lee al­so made clear that this bill would not af­fect states’ abil­i­ty to craft their own laws re­gard­ing biosim­i­lar sub­sti­tu­tion, as many al­ready have laws around in­ter­change­abil­i­ty.

“It would mere­ly send an ac­cu­rate sig­nal to the states re­gard­ing the na­ture of in­ter­change­abil­i­ty,” he said.

Sen­ate health com­mit­tee chair Bernie Sanders (I-VT) on Wednes­day al­so in­tro­duced a new bill that would ex­pand the health care work­force in the US and sep­a­rate­ly, re­move the in­ter­change­abil­i­ty des­ig­na­tion to re­duce “the reg­u­la­to­ry bur­den on biosim­i­lar man­u­fac­tur­ers and en­hanc­ing ac­cess to more af­ford­able bi­o­log­ics.”