Amgen’s Leah Christl makes the case to keep the interchangeability designation for biosimilars

Am­gen and its port­fo­lio of 11 biosim­i­lars is stand­ing be­hind in­ter­change­abil­i­ty, say­ing the des­ig­na­tion should not be re­scind­ed and that the FDA needs to re­tain its reg­u­la­to­ry flex­i­bil­i­ties.

The po­si­tion puts Am­gen in op­po­si­tion to bi­par­ti­san leg­is­la­tion that’s push­ing to re­move the in­ter­change­abil­i­ty des­ig­na­tion for biosim­i­lars and to the in­dus­try-led Biosim­i­lars Fo­rum, whose ex­ec­u­tive di­rec­tor re­cent­ly told End­points News they were back­ing the push to re­move the des­ig­na­tion. The in­ter­change­abil­i­ty des­ig­na­tion al­lows biosim­i­lars to be swapped with their brand name ref­er­ence prod­ucts with­out the in­ter­ven­tion of a pre­scriber.

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