Lil­ly, No­vo Nordisk fight in­sulin biosim­i­lars with tweaks to FDA draft guid­ance

As Amer­i­cans with di­a­betes con­tin­ue to die be­cause they can­not af­ford their in­sulin, two of the three in­sulin man­u­fac­tur­ers in the US are do­ing their best to try to al­ter FDA draft guid­ance that seeks to bring more in­sulin com­pe­ti­tion to mar­ket.

The draft guid­ance, un­veiled last No­vem­ber, ex­plains how in­sulin biosim­i­lar de­vel­op­ers may not need to con­duct com­par­a­tive clin­i­cal im­muno­genic­i­ty stud­ies un­der cer­tain cir­cum­stances.

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