Roche clinch­es EU ap­proval for MabThera in rare au­toim­mune in­di­ca­tion — will it boost dwin­dling sales amid biosimi­ar com­pe­ti­tion?

Roche is pil­ing up an­oth­er Eu­ro­pean ap­proval for its MabThera fran­chise just as biosim­i­lars are se­ri­ous­ly erod­ing sales of the cru­cial drug, bet­ter known in the US as Rit­ux­an.

The Eu­ro­pean Com­mis­sion hand­ed the OK for mod­er­ate to se­vere cas­es of pem­phi­gus vul­garis, a rare skin blis­ter­ing dis­ease cur­rent­ly treat­ed by cor­ti­cos­teroids. This is an in­di­ca­tion where Roche swept the pri­or­i­ty re­view, break­through ther­a­py and or­phan drug des­ig­na­tions be­fore nab­bing the FDA ap­proval last June — and one which hasn’t seen a new treat­ment op­tion in 60 years, ac­cord­ing to the com­pa­ny.

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