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.

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