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

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.