FDA re­vers­es course, de­cides not to add suf­fix­es to old­er bi­o­log­ics’ non­pro­pri­etary names

The FDA has de­cid­ed not to go back and re­name bi­o­log­ics’ non­pro­pri­etary names with non­sense suf­fix­es, as it once said it would, rais­ing ques­tions about the con­fu­sion that will like­ly come from a sub­set of bi­o­log­ics’ and biosim­i­lars’ names con­tain­ing suf­fix­es while an­oth­er sub­set of bi­o­log­ics’ names will not con­tain suf­fix­es.

Since 2015, the FDA has been adding the mean­ing­less suf­fix­es to biosim­i­lars’ non­pro­pri­etary names as part of an ef­fort to im­prove phar­ma­covig­i­lance. And since No­vem­ber 2017, the agency al­so be­gan adding the suf­fix­es to new­ly ap­proved bi­o­log­ics’ names, with the in­ten­tion of go­ing back and adding suf­fix­es to all bi­o­log­ics’ non­pro­pri­etary names.

Cur­rent­ly, all 17 ap­proved biosim­i­lars have been ap­proved with the four-let­ter suf­fix­es, as have the prop­er names of 27 orig­i­na­tor bi­o­log­ics.

Scott Got­tlieb

But now, ac­cord­ing to draft guid­ance re­leased Thurs­day, the FDA says that the non­pro­pri­etary names of pre­vi­ous­ly ap­proved prod­ucts “need not be re­vised in or­der to ac­com­plish the ob­jec­tives of the nam­ing con­ven­tion.” The FDA in Jan­u­ary 2017 pub­lished its fi­nal guid­ance on how the suf­fix­es would be added.

The ob­jec­tives from that plan — “phar­ma­covig­i­lance and safe use” — can be ac­com­plished, the FDA says, by ap­ply­ing the nam­ing con­ven­tion to bi­o­log­i­cal prod­ucts “at the time they are li­censed” and “with­out ap­ply­ing it to li­censed bi­o­log­i­cal prod­ucts that do not con­tain a suf­fix in their prop­er names.”

So why is the FDA de­cid­ing not to go back and re­name bi­o­log­ics with the suf­fix­es?

“This ap­proach is in­tend­ed to min­i­mize the po­ten­tial bur­den for spon­sors and the health­care sys­tems, and to avoid po­ten­tial con­fu­sion for health­care providers and pa­tients, giv­en that the non­pro­pri­etary names of drugs sel­dom change postap­proval,” the draft guid­ance says.

But the guid­ance will al­so mean that all biosim­i­lars will have ran­dom non­sense suf­fix­es, while their ref­er­ence prod­ucts will not have the suf­fix­es — po­ten­tial­ly rais­ing ques­tions about whether the prod­ucts are sim­i­lar.

The Biosim­i­lars Fo­rum said in a state­ment that the FDA’s “de­ci­sion aban­dons the ret­ro­spec­tive ad­di­tion of a suf­fix to orig­i­na­tion bi­o­log­ics, lead­ing to an un­sub­stan­ti­at­ed no­tion that strict phar­ma­covig­i­lance is on­ly es­sen­tial for biosim­i­lars.”

FDA Com­mis­sion­er Scott Got­tlieb said in a state­ment: “We ex­pect that as time goes on, and more bi­o­log­i­cal prod­ucts are in­tro­duced to the mar­ket with dis­tin­guish­able suf­fix­es, pa­tients and providers in­creas­ing­ly will un­der­stand that the suf­fix­es re­flect a con­sis­tent nam­ing con­ven­tion and are not an in­di­ca­tor of prod­uct qual­i­ty.”

And for in­ter­change­able prod­ucts, the draft guid­ance says unique suf­fix­es will be used to “fa­cil­i­tate man­u­fac­tur­er-spe­cif­ic phar­ma­covig­i­lance.”

“An ap­pli­cant for a pro­posed in­ter­change­able prod­uct sub­mit­ted un­der sec­tion 351(k) of the PHS Act should pro­pose a suf­fix com­posed of four low­er­case let­ters for use as the dis­tin­guish­ing iden­ti­fi­er in­clud­ed in the prop­er name des­ig­nat­ed by FDA at the time of li­cen­sure. Such sub­mis­sions can be made dur­ing the in­ves­ti­ga­tion­al new drug ap­pli­ca­tion (IND) phase or at the time of BLA sub­mis­sion. An ap­pli­cant should sub­mit up to 10 pro­posed suf­fix­es, as de­scribed in the Nam­ing Guid­ance, in the or­der of the ap­pli­cant’s pref­er­ence,” the draft says.

But the FDA al­so says that it “does not in­tend to ap­ply the nam­ing con­ven­tion de­scribed in the Nam­ing Guid­ance to tran­si­tion bi­o­log­i­cal prod­ucts.”

Sim­i­lar­ly, the FDA is “re­con­sid­er­ing whether vac­cines should be with­in the scope of the nam­ing con­ven­tion.” Sanofi wrote to the FDA last month ex­plain­ing how the ad­di­tion of suf­fix­es to vac­cine la­bels could cause con­fu­sion among health care providers and neg­a­tive­ly im­pact pub­lic health.

“In view of the ex­ist­ing frame­work for en­sur­ing safe­ty re­port­ing and mon­i­tor­ing for vac­cines, the agency is care­ful­ly con­sid­er­ing whether the in­for­ma­tion that’s al­ready avail­able to us through iden­ti­fi­ca­tion sys­tems as­so­ci­at­ed with the ad­min­is­tra­tion of vac­cines is suf­fi­cient­ly ro­bust for en­sur­ing phar­ma­covig­i­lance such that we may not need dis­tin­guish­able prop­er names with suf­fix­es for vac­cines,” Got­tlieb added.

The FDA’s use of the non­sense suf­fix­es is al­so unique in that no oth­er coun­try in the world has em­ployed their use. Cana­da re­cent­ly de­cid­ed to not use suf­fix­es in the non-pro­pri­etary names of bi­o­log­ics or biosim­i­lars.

Read more: Pro­ce­dures for Han­dling Re­quests for Non­pro­pri­etary Name Suf­fix Re­view for Bi­o­log­i­cal Prod­ucts New­ly Li­censed Un­der Sec­tion 351of the PHS Act​

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

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