Fate of cost-sav­ing biosim­i­lar drugs may hinge on nam­ing pol­icy

Modern Healthcare - - NEWS - By Steven Ross John­son

What’s in a name? A lot, ac­cord­ing to groups bat­tling over whether biosim­i­lar phar­ma­ceu­ti­cal prod­ucts should be al­lowed to use the same non­pro­pri­etary name as branded prod­ucts.

In March, in its first ap­proval of a biosim­i­lar prod­uct, the Food and Drug Ad­min­is­tra­tion des­ig­nated the San­doz prod­uct Zarxio with the place­holder non­pro­pri­etary name “fil­gras­tim-sndz.” That was a com­pro­mise from la­bel­ing it sim­ply as fil­gras­tim, the non­pro­pri­etary name for the brand-name prod­uct, Ne­u­pogen, for which it is con­sid­ered a biosim­i­lar.

The FDA said fil­gras­tim-sndz was a tem­po­rary place­holder name and should not be viewed “as re­flec­tive of the agency’s de­ci­sion on a com­pre­hen­sive nam­ing pol­icy for biosim­i­lar and other bi­o­log­i­cal prod­ucts.”

Ex­perts es­ti­mated that Zarxio could be sold at a dis­count of up to 35% of the price of Ne­u­pogen, a block­buster can­cer biologic pro­duced by Am­gen, which can cost about $3,000 for 10 in­jec­tion treat­ments.

The FDA nam­ing des­ig­na­tion for Zarxio fol­lows the model pro­posed last July by the World Health Or­ga­ni­za­tion, which over­sees the In­ter­na­tional Non­Pro­pri­etary Names sys­tem (INN). The WHO rec­om­mended that biosim­i­lars re­ceive the same non­pro­pri­etary name but with a four-let­ter code at the end.

But that com­pro­mise did not sat­isfy those who want to see biosim­i­lars des­ig­nated with the same INN as the biologic prod­ucts whose func­tions they repli­cate. It’s also op­posed by those who ar­gue that sim­i­lar la­bel­ing poses pa­tient-safety risks. The lat­ter group, which in­cludes brand-name drug­mak­ers and some physi­cian groups, says giv­ing biosim­i­lars the same INN des­ig­na­tion as the branded biologic prod­ucts could lead to con­fu­sion among physi­cians and pa­tients over which drugs they can trust to be safe and ef­fec­tive. They also say us­ing the same name could make it harder to track ad­verse re­ac­tions.

“A biosim­i­lar will not have the same struc­ture, and there can be a lot of things that hap­pen dur­ing the man­u­fac­tur­ing process that will lead to a drug that is sim­i­lar but not the same as the ini­tial drug,” said Dr. Kent Hus­ton, a rheuma­tol­o­gist at the Cen­ter for Rheumatic Dis­ease in Kansas City, Mo., speak­ing on be­half of the Amer­i­can Col­lege of Rheuma­tol­ogy. (In 2014, Hus­ton re­ceived pay­ments from Am­gen and other man­u­fac­tur­ers to­tal­ing about $1,800, ac­cord­ing to the CMS’ Open Pay­ments web­site).

Some ex­perts pre­dict that how biosim­i­lar prod­ucts are la­beled will be a key fac­tor de­ter­min­ing the suc­cess of the biosim­i­lars in­dus­try, which is seen as im­por­tant to the fu­ture of con­trol­ling ris­ing drug costs. The nam­ing is­sue will be par­tic­u­larly im­por­tant when some biosim­i­lar prod­ucts even­tu­ally re­ceive FDA ap­proval for in­ter­change­abil­ity, mean­ing that phar­ma­cists can switch from a branded biologic to a cheaper biosim­i­lar with­out physi­cian con­sent, as they do with chem­i­cal generic drugs.

“In the near term, the first-or­der ob­sta­cles (for the biosim­i­lars in­dus­try) are the lack of in­ter­change­abil­ity and the preven­tion of au­to­matic sub­sti­tu­tion,” said Andy Paster­nak, a part­ner and healthcare an­a­lyst at Bain & Co. in Chicago, a man­age­ment con­sult­ing firm. “Once prod­ucts over­come those, the nam­ing is­sue be­comes more sig­nif­i­cant.”

The FDA is sched­uled to is­sue guid­ance this year ad­dress­ing the la­bel­ing is­sue. None of the ex­perts in­ter­viewed for this ar­ti­cle were will­ing to pre­dict what the agency’s po­si­tion will be.

A biosim­i­lar is a prod­uct that copies an orig­i­nal biologic drug but is not iden­ti­cal in its com­po­si­tion or in the way in which it’s man­u­fac­tured. That’s dif­fer­ent from chem­i­cal generic drugs.

Some es­ti­mates have pro­jected the biosim­i­lars mar­ket in the U.S. will grow to $60 bil­lion by 2020 as the patent pro­tec­tions on a num­ber of biologic med­i­ca­tions are set to ex­pire over the next sev­eral years.

Last De­cem­ber, Ex­press Scripts re­leased a re­port es­ti­mat­ing ap­proval of Zarxio could save pa­tients more than $5 bil­lion in drug costs over the next decade. The re­port es­ti­mated that as much as $250 bil­lion could be saved over the next decade if biosim­i­lars be­ing de­vel­oped are ap­proved for 11 biologic drugs that are slated to lose patent pro­tec­tion in the com­ing years.

Many see the growth of biosim­i­lars as a way to in­tro­duce com­pe­ti­tion to a mar­ket that’s been dom­i­nated for years by a rel­a­tively small num­ber of bi­o­log­ics man­u­fac­tur­ers such as Am­gen and Ge­nen­tech. Biologic prod­ucts are among the

most ex­pen­sive pre­scrip­tion med­i­ca­tions, with some cost­ing more than $100,000 for a year’s worth of treat­ment.

The po­ten­tial cost sav­ings as­so­ci­ated with biosim­i­lar prod­ucts have led in­sur­ers, pa­tient ad­vo­cacy groups, phar­macy ben­e­fit man­agers and generic-drug mak­ers to rally in sup­port of biosim­i­lars. They’ve urged the FDA to des­ig­nate such drugs with the same non­pro­pri­etary name as the orig­i­nal biologic.

But a ma­jor safety con­cern voiced by skep­tics of biosim­i­lars in­volves im­muno­genic­ity, or the way in which a drug pro­vokes an im­mune re­sponse in the body. Un­like generic drugs, biosim­i­lars are not ex­act repli­cas of the branded biologic. They work in the same bi­o­log­i­cal man­ner but are not de­rived from the same liv­ing ma­te­ri­als and are not pro­duced in the same way.

Hus­ton said giv­ing biosim­i­lars a dif­fer­ent name would al­low in­ves­ti­ga­tors to de­ter­mine what types of ad­verse re­ac­tions oc­cur with the long-term use of a biosim­i­lar com­pared with use of the orig­i­nal biologic prod­uct. “The im­muno­genic­ity risk of a biosim­i­lar could be com­pletely dif­fer­ent than the orig­i­nal prod­uct,” he said.

Those who fa­vor ap­ply­ing the same INN to both biologic and biosim­i­lars say cur­rent meth­ods for track­ing ad­verse re­ac­tions to drugs—which in­clude the use of the Na­tional Drug Code iden­ti­fi­ca­tion sys­tem, plus the name of the brand and man­u­fac­turer —are ad­e­quate to ad­dress safety con­cerns.

Ralph Neas, pres­i­dent of the Generic Phar­ma­ceu­ti­cal As­so­ci­a­tion, said brand-name drug­mak­ers “con­tinue to do ev­ery­thing pos­si­ble to try to erect bar­ri­ers and hur­dles to make it more dif­fi­cult for pa­tients and con­sumers to have ac­cess to af­ford­able medicines in biosim­i­lars.”

His group re­cently sent a let­ter to the FDA call­ing for bi­o­log­ics and biosim­i­lars to share the same name “in or­der to en­sure pa­tient safety and avoid con­fu­sion among providers and dis­pensers.” It was signed by 19 other or­ga­ni­za­tions, in­clud­ing phar­macy ben­e­fits man­agers CVS Health and Ex­press Scripts, the Healthcare Sup­ply Chain As­so­ci­a­tion, public sec­tor la­bor unions and health in­sur­ance groups.

De­vel­op­ers of biosim­i­lar prod­ucts such as San­doz have been mired in le­gal bat­tles for the past sev­eral years with man­u­fac­tur­ers of branded biologic prod­ucts that seek to block or de­lay the in­tro­duc­tion of biosim­i­lars. In ad­di­tion to the law­suits, biosim­i­lars also face reg­u­la­tory chal­lenges that could slow their growth, Bain an­a­lyst Paster­nak said. A key is­sue is in­ter­change­abil­ity.

The FDA has two path­ways for li­cens­ing of biosim­i­lars. One leads to be­ing des­ig­nated as “sim­i­lar” in ef­fi­cacy and safety to an orig­i­nal biologic. The other path­way is to be ap­proved as be­ing “in­ter­change­able,” which re­quires a much higher re­view stan­dard and could take years and mil­lion of dol­lars to ob­tain the needed clin­i­cal trial data. None of the biosim­i­lar prod­ucts cur­rently un­der FDA re­view are in the in­ter­change­able path­way.


Ex­perts es­ti­mated that Zarxio could be sold at a dis­count of up to 35% of the price of Ne­u­pogen, a block­buster can­cer biologic pro­duced by Am­gen, which can cost about $3,000 for 10 in­jec­tion treat­ments.

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