Pfizer to launch cheaper ver­sion of J&J im­mune drug Rem­i­cade

In­flec­tra, will be in stores late Novem­ber

Kuwait Times - - HEALTH & SCIENCE -

TREN­TON, NEW YORK: Drug­maker Pfizer said Mon­day that it will launch a less-ex­pen­sive ver­sion of ri­val John­son & John­son’s block­buster im­mune dis­or­der drug, Rem­i­cade. Pfizer Inc.’s ver­sion, called In­flec­tra, will hit phar­ma­cies in late Novem­ber. It will be only the sec­ond so-called biosim­i­lar drug avail­able in the US

Rem­i­cade, long J&J’s top-sell­ing drug, is ap­proved for treat­ing rheuma­toid arthri­tis, pso­ri­a­sis, colitis and other im­mune sys­tem dis­or­ders. Biosim­i­lars are near-copies of bi­o­logic drugs, which are very ex­pen­sive in­jected medicines that are “man­u­fac­tured” in­side liv­ing cells, rather than by mix­ing chem­i­cals to­gether.

New York-based Pfizer said it will sell In­flec­tra at a 15 per­cent dis­count to the list price for Rem­i­cade. J&J said in a state­ment it will com­pete with In­flec­tra “through a va­ri­ety of in­no­va­tive con­tract­ing op­tions, dis­counts and re­bates to pay­ers, providers and phar­macy ben­e­fit man­agers” to keep Rem­i­cade af­ford­able for pa­tients.

The cost for Rem­i­cade varies, be­cause the dosage de­pends on the pa­tient’s weight, the im­mune dis­or­der be­ing treated and whether the pa­tient is be­gin­ning treat­ment or on a lower main­te­nance dose, but it’s roughly $2,600 per month with­out in­sur­ance. John­son & John­son said it gives in­sur­ers dis­counts and re­bates on their costs, that many in­sured pa­tients have very low co­pay­ments and that those with­out in­sur­ance can ap­ply for fi­nan­cial aid.

Cur­rently, there’s only one biosim­i­lar for sale in the US, Zarxio from Swiss drug­maker No­var­tis AG’s generic drug di­vi­sion, San­doz. Zarxio was launched in Septem­ber 2015, at a 15 per­cent price dis­count to Am­gen Inc.’s Ne­u­pogen, which boosts white blood cell production to pre­vent in­fec­tions in pa­tients with cancer and a few other con­di­tions.

US in­sur­ers, doc­tors and pa­tients have been ea­ger for ac­cess to cheaper ver­sions of bi­o­logic drugs, which can cost $100,000 or more an­nu­ally. Last year, six of the 10 best­selling medicines by global rev­enue were bi­o­log­ics, with about $49 bil­lion in com­bined sales.

More than 20 biosim­i­lar ver­sions of seven dif­fer­ent medicines now are on the mar­ket in Europe. Bu in the US, biosim­i­lars have been de­layed by the lengthy process of set­ting up rules for their ap­proval, as well as law­suits be­tween drug­mak­ers.

A 2010 law al­lows near-copies of bi­o­logic drugs, known as biosim­i­lars, after 12 years of mar­ket ex­clu­siv­ity for the orig­i­nal. But so far the mak­ers of orig­i­nal drugs fac­ing biosim­i­lar ri­vals have been try­ing to de­lay that com­pe­ti­tion with law­suits over whether the orig­i­nal drug still has a patent in force that pro­tects its mo­nop­oly.

In the case of In­flec­tra, lit­i­ga­tion be­tween Pfizer and John­son & John­son, which is based in New Brunswick, New Jersey, is con­tin­u­ing over whether Rem­i­cade still has a valid patent. A fed­eral judge in Au­gust ruled the patent was in­valid, but J&J is ap­peal­ing that. If Pfizer loses the lit­i­ga­tion, it would face sub­stan­tial fi­nan­cial penal­ties be­cause it’s mak­ing what’s called an “at-risk” launch of In­flec­tra.

Rem­i­cade is known chem­i­cally as in­flix­imab. In­flec­tra will bear the chem­i­cal name in­flix­imab-dyyb, as the US Food and Drug Ad­min­is­tra­tion re­quires that biosim­i­lar drugs have a suf­fix at­tached to their name to dis­tin­guish the biosim­lar from the orig­i­nal medicine.

Ac­cord­ing to J&J, Rem­i­cade has treated more than 2.6 mil­lion peo­ple worldwide since 1998. —AP

NEW YORK: In this Mon­day, Nov 23, 2015, file photo, the Pfizer logo is dis­played at world head­quar­ters. —AP

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