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Spotlight on drug pricing could be catalyst for change in US biosimilar landscape | Endpoints News

While biosim­i­lar mak­ers have long es­tab­lished them­selves in Eu­rope, only a few copy­cat ver­sions of bi­o­log­ics have launched in the nascent US mar­ket, which is be­gin­ning to show signs of ma­tur­ing, but is com­pli­cated by a re­im­burse­ment land­scape frac­tured by mul­ti­ple play­ers. The spot­light on drug pric­ing, how­ever, may at long last pro­vide the cat­a­lyst for change.

Ear­lier this week, the Ger­man drug­maker said it had de­cided to focus all its ef­fort into launch­ing its Hu­mira biosim­i­lar Cyl­tezo in the United States, and would aban­don its en­tire biosim­i­lar de­vel­op­ment pro­gram else­where. Mean­while Ab­b­Vie has not been able to keep biosim­i­lar com­pe­ti­tion at bay in Eu­rope, where at least four Hu­mira copy­cats have al­ready been launched, forc­ing the com­pany to slash the rheuma­toid arthri­tis drug’s price by 80% in Eu­ro­pean mar­kets to re­main com­pet­i­tive.

The few copy­cats that have launched on the US mar­ket out of the 15 that have se­cured FDA ap­proval have not so far gar­nered sig­nif­i­cant mar­ket share com­pared to their Eu­ro­pean coun­ter­parts — largely due to pric­ing dy­nam­ics and re­im­burse­ment hur­dles. Yet with po­lit­i­cal pres­sure reach­ing full boil on drug pric­ing in the United States, newer en­trants may be forced to tem­per their pric­ing strat­egy, which could en­tice in­sur­ance cov­er­age, and help their mak­ers chip away at the mo­nop­oly of es­tab­lished branded bi­o­log­ics.

On Wednes­day, Teva $TEVA and Cell­trion’s once-re­jected biosim­i­lar for Roche’s non-Hodgkin’s lym­phoma drug Rit­uxan was ap­proved by the FDA — but the two part­ners have not dis­closed their pric­ing plans for the drug, Trux­ima, or of­fered a launch date. Sales of Rit­uxan, one of Roche’s ar­se­nal of can­cer block­busters, have al­ready plum­meted in Eu­rope thanks to biosim­i­lar com­pe­ti­tion. Teva and Cell­trion are also gear­ing up for a US ap­proval for a Her­ceptin biosim­i­lar, which could deal a fur­ther blow to Roche’s $20 bil­lion can­cer fran­chise.

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Spotlight on drug pricing could be catalyst for change in US biosimilar landscape – Endpoints News.