J&J faces its sec­ond ri­val Rem­i­cade knock­off as FDA gives Mer­ck a shot at a $7B fran­chise

The FDA has ap­proved a new knock­off of J&J’s top earn­ing drug Rem­i­cade, which may fi­nal­ly start to shift the mar­ket dy­nam­ics to­ward greater com­pe­ti­tion with low­er prices.

This new one is dubbed Ren­flex­is and comes from Sam­sung Bioepis, one of the big play­ers in the biosim­i­lars field. And it ar­rives in the US mar­ket close to a year af­ter the EMA ap­proved it for Eu­rope.

J&J’s Rem­i­cade earned close to $7 bil­lion last year, mak­ing this by far its biggest drug in the port­fo­lio. And as J&J not­ed a few days ago dur­ing its Q1 call with an­a­lysts, the phar­ma gi­ant has yet to feel much of an im­pact from the first Rem­i­cade biosim­i­lar from Pfiz­er, In­flec­tra (in­flix­imab-dyyb), which was de­vel­oped by Cell­tri­on and then bagged by the phar­ma gi­ant in its ac­qui­si­tion of Hos­pi­ra. That was ap­proved last fall.

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