Is FDA do­ing enough to bring biosim­i­lars to mar­ket? Ex­perts dis­cuss

As the num­ber of biosim­i­lar ap­provals con­tin­ues to rise in the US, the num­ber of biosim­i­lar launch­es con­tin­ues to lag, but ex­perts ex­plained how this is more of a le­gal is­sue than a prob­lem with the FDA.

Chad Land­mon, part­ner at Ax­inn, Vel­trop & Harkrid­er LLP, of­fered an overview on Mon­day at the As­so­ci­a­tion of Ac­ces­si­ble Med­i­cines’ con­fer­ence in Bethes­da, MD, of the biosim­i­lar “patent dance,” which is the con­vo­lut­ed and of­ten un­cer­tain process by which the patent is­sues are re­solved ahead of a biosim­i­lar’s launch.

Un­like on the gener­ic side, which has an Or­ange Book of patent and ex­clu­siv­i­ty da­ta, biosim­i­lar com­pa­nies do not have an ad­min­is­tra­tive record of the date of first li­cen­sure or ex­clu­siv­i­ty pe­ri­od, Land­mon ex­plained. He al­so touched on oth­er lim­i­ta­tions of the FDA’s Pur­ple Book and how to im­prove it with leg­is­la­tion.

“The agency can take some ac­tions on its own, like list­ing ex­clu­siv­i­ties, but one of the things that would be most help­ful is to re­quire the patents to be list­ed and you may need some penal­ties for not list­ing those in the Pur­ple Book, which does re­quire Con­gress,” Land­mon said.

On the small mol­e­cule side, there may be be­tween one and three patents at is­sue, where­as with bi­o­log­ics, 75 patents may be at is­sue, and go­ing 75-0 will be dif­fi­cult for the lawyers on the biosim­i­lar side, he not­ed. He al­so point­ed to sev­er­al House and Sen­ate bills in­tro­duced in the past year that could add some cer­tain­ty to the biosim­i­lar space, al­though it’s un­clear which ones will make their way through Con­gress.

In ad­di­tion to un­cer­tain­ty on the le­gal side, there is al­so un­cer­tain­ty on the re­turn on in­vest­ment (ROI) that biosim­i­lar de­vel­op­ers are see­ing.

Gillian Wool­lett Avalere

Gillian Wool­lett, se­nior vice pres­i­dent of Avalere Health, dis­cussed how com­pa­nies may be bail­ing on de­vel­op­ing biosim­i­lars be­cause it’s un­clear how many biosim­i­lar en­trants are nec­es­sary (she of­fered in­flix­imab as an ex­am­ple of com­pe­ti­tion not work­ing), and if you can’t get that ROI, com­pa­nies don’t want to in­vest $100 mil­lion to $500 mil­lion to bring a biosim­i­lar to mar­ket.

But the FDA has the au­thor­i­ty to speed up the ap­provals of biosim­i­lars, Wool­lett added, not­ing the agency can waive what­ev­er clin­i­cal stud­ies it deems nec­es­sary. She said the FDA’s re­cent biosim­i­lar ac­tion plan is “am­bi­tious yet vague,” ex­plain­ing that com­pa­nies feel ob­lig­at­ed to fol­low FDA guid­ance doc­u­ments and the agency could be more proac­tive at tak­ing out cer­tain re­quire­ments.

“In­ter­change­abil­i­ty is large­ly ir­rel­e­vant,” Wool­lett said, not­ing that it’s on­ly for those bi­o­log­ics ad­min­is­tered at the phar­ma­cy lev­el and not by physi­cians, which is a sub­set of bi­o­log­ics. She al­so ex­plained how the des­ig­na­tion could al­so be detri­men­tal to in­sulin prod­ucts and oth­er in­sulin biosim­i­lars, at least in terms of per­cep­tion.

“If there’s one thing we have to deal with it’s deal­ing with the mis­in­for­ma­tion” on biosim­i­lars, Wool­lett added, say­ing the FDA has a re­spon­si­bil­i­ty to cor­rect some of the mis­lead­ing com­ments made by cer­tain com­pa­nies.

RAPS: 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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