Pfiz­er bris­tles at 'mis­lead­ing' com­ments from Big Phar­ma ri­vals Am­gen, Genen­tech on biosim­i­lars

Tak­ing is­sue with Am­gen, Genen­tech and oth­er ref­er­ence prod­uct spon­sors’ dis­sem­i­na­tion of mis­lead­ing in­for­ma­tion on biosim­i­lars, Pfiz­er is ask­ing the FDA to take ac­tion with new guid­ance on what’s ac­cept­able.

In a cit­i­zen pe­ti­tion filed Mon­day, Pfiz­er notes ex­am­ples of what it calls “in­ap­pro­pri­ate com­mu­ni­ca­tions” and “mis­lead­ing rep­re­sen­ta­tions and sug­ges­tions by ref­er­ence prod­uct spon­sors.” The is­sue at hand isn’t so much that the in­for­ma­tion is wrong, but that the state­ments im­ply that biosim­i­lars are not as safe or as ef­fec­tive as ref­er­ence prod­ucts.

Lisa Skeens

Pfiz­er says it has ob­served some ref­er­ence prod­uct spon­sor-cre­at­ed physi­cian- and pa­tient-di­rect­ed ma­te­ri­als that “mis­char­ac­ter­ize im­por­tant el­e­ments of the biosim­i­lar cri­te­ria and cre­ate doubt and con­fu­sion about the safe­ty and ef­fi­ca­cy of biosim­i­lars.”

For in­stance, a tex­tu­al sum­ma­ry com­par­ing biosim­i­lars and gener­ics on a Genen­tech web­site ex­plains that the “FDA re­quires a biosim­i­lar to be high­ly sim­i­lar, but not iden­ti­cal to the [ref­er­ence prod­uct],” but Pfiz­er notes that the ex­pla­na­tion “fails to state that an ap­proved biosim­i­lar must have no clin­i­cal­ly mean­ing­ful dif­fer­ences from the ref­er­ence prod­uct.”

Sim­i­lar­ly, an Am­gen YouTube video im­plies that switch­ing to a biosim­i­lar from a ref­er­ence prod­uct is risky, though a re­cent re­view found the op­po­site. Pfiz­er al­so points to Rem­i­cade ads from Janssen Biotech that failed to men­tion a biosim­i­lar works in the same way as the ref­er­ence prod­uct.

Re­quest for FDA

In call­ing for the FDA to craft a new guid­ance on what’s mis­lead­ing and what isn’t, Pfiz­er al­so asks for the guid­ance to ad­dress ref­er­ence prod­uct spon­sor com­mu­ni­ca­tions com­par­ing ref­er­ence bi­o­log­ics to biosim­i­lars, in­clud­ing in­ter­change­able biosim­i­lars, “that would and would not be con­sid­ered mis­lead­ing.

“Pro­mo­tion­al state­ments by a ref­er­ence prod­uct spon­sor that di­rect­ly or im­plic­it­ly com­mu­ni­cate that biosim­i­lar prod­ucts dif­fer from in­ter­change­able prod­ucts in any re­gard be­yond the ad­di­tion­al da­ta re­quired to per­mit sub­sti­tu­tion with­out physi­cian in­ter­ven­tion at the phar­ma­cy lev­el are plain­ly mis­lead­ing,” Lisa Skeens, VP of glob­al reg­u­la­to­ry af­fairs at Pfiz­er, wrote.

Skeens calls on the FDA to tar­get cer­tain ads or pro­mo­tion­al ma­te­ri­als that sow con­fu­sion and mis­trust among pa­tients and physi­cians. And Pfiz­er al­so wants the FDA to clar­i­fy that biosim­i­lar spon­sors may dis­cuss clin­i­cal and oth­er da­ta with physi­cians and in pro­mo­tion­al ma­te­ri­als.

She al­so notes that while it’s gen­er­al­ly out of the FDA’s purview, “pay­er re­im­burse­ment poli­cies are in fact im­ped­ing adop­tion of biosim­i­lars,” though “dis­sem­i­na­tion of false or mis­lead­ing in­for­ma­tion about the safe­ty or ef­fi­ca­cy of biosim­i­lars, whether to pa­tients and pre­scribers or di­rect­ly to pay­ers, has the po­ten­tial to af­fect pay­er de­ci­sions about biosim­i­lar re­im­burse­ment, as well as pa­tient and health­care pro­fes­sion­al con­fi­dence in biosim­i­lars.”

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

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