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 news@raps.org for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,900+ biopharma pros reading Endpoints daily — and it's free.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.