FDA ex­perts unan­i­mous­ly en­dorse Am­gen’s biosim­i­lar of Ab­b­Vie’s $14B fran­chise drug

An FDA pan­el of­fered a clear en­dorse­ment of Am­gen’s fran­chise-bust­ing biosim­i­lar of Ab­b­Vie’s $14 bil­lion bi­o­log­ic Hu­mi­ra.

The vote was unan­i­mous in fa­vor of an ap­proval on a broad slate of in­di­ca­tions.

“I thought the vot­ing was easy,” not­ed pan­elist Steve Sol­ga, the chief of gas­troen­terol­o­gy at St. Luke’s Uni­ver­si­ty Hos­pi­tal, echo­ing the pan­el’s con­sen­sus that there could be lit­tle to ar­gue with the FDA, par­tic­u­lar­ly as more thorny is­sues were not cov­ered in the dis­cus­sion.

FDA in­sid­ers of­fered their ve­he­ment sup­port for the ap­pli­ca­tion, re­peat­ing an in­sid­er agency re­view con­clud­ing that Am­gen had pro­vid­ed all the da­ta need­ed to war­rant an ap­proval of ABP501 for all the in­di­ca­tions now al­lowed to Hu­mi­ra, Ab­b­Vie’s most lu­cra­tive ther­a­py.

Ab­b­Vie, though, had a long line­up of pa­tient ad­vo­cates who main­tained that un­less the drug had been grant­ed in­ter­change­able sta­tus, it shouldn’t get the broad ap­proval sought by Am­gen. And Ab­b­Vie sent a rep­re­sen­ta­tive of its own to un­der­score the ar­gu­ment that there were sig­nif­i­cant dif­fer­ences to con­sid­er, which should trump the ar­gu­ment in fa­vor of “ex­trap­o­lat­ing” the da­ta in for a host of in­di­ca­tions, in­clud­ing pe­di­atric use.

The “straw man” ar­gu­ment gained some trac­tion among pan­el mem­bers who were con­cerned that the da­ta var­ied by batch, and even ques­tioned whether Ab­b­Vie had ever ad­e­quate­ly made its case for all of its own ap­provals.

The out­side ex­perts, though, con­clud­ed with the FDA – which stuck with a sol­id front in fa­vor of an ap­proval on all in­di­ca­tions – that there were no “mean­ing­ful” dif­fer­ences be­tween Am­gen’s knock­off and the ref­er­ence prod­uct from Ab­b­Vie. But a num­ber of pan­el mem­bers raised the point that there was no built-in re­quire­ment of a Phase IV fol­lowup study to make sure the drug worked as billed.

The stamp of ap­proval marks a sig­nif­i­cant new phase for the adop­tion of biosim­i­lars. No­var­tis was the first to win an ap­proval for a biosim­i­lar in the U.S., but a range of knock­offs in the first wave is meet­ing with open arms at the reg­u­la­tor. To­mor­row, Am­gen gets to switch roles, chang­ing from of­fense to de­fense as it seeks to pre­vent an ap­proval for a biosim­i­lar from No­var­tis of En­brel, which pro­vides bil­lions of dol­lars in an­nu­al rev­enue to…Am­gen.

This ar­gu­ment is far from over. Ab­b­Vie is fight­ing a tough le­gal war fo­cus­ing on its patents for Hu­mi­ra, and it’s mak­ing more progress in the court than it has at the FDA. But Am­gen will hap­pi­ly mark the reg­u­la­to­ry win.

“We’re pleased with to­day’s unan­i­mous vote of the FDA’s Arthri­tis Ad­vi­so­ry Com­mit­tee to rec­om­mend ap­proval of ABP 501 in all avail­able in­di­ca­tions to the ref­er­ence prod­uct,” said Sean E. Harp­er, M.D., ex­ec­u­tive vice pres­i­dent of Re­search and De­vel­op­ment at Am­gen. “The Com­mit­tee’s fa­vor­able vote is an ex­cit­ing step to­ward rec­og­niz­ing ABP 501 as an im­por­tant treat­ment op­tion for pa­tients with in­flam­ma­to­ry dis­eases. We look for­ward to con­tin­u­ing to work with the FDA as they com­plete their re­view of Am­gen’s BLA for ABP 501.”


Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

Martin Shkreli (Shutterstock)

Mar­tin Shkre­li con­tin­ued to or­ches­trate an­ti-com­pet­i­tive schemes for Dara­prim be­hind bars — FTC

Martin Shkreli didn’t just blog, read up on drug development news and run his biotech business with a contraband cell phone in prison. According to the FTC, he was also coordinating the anticompetitive scheme to shield Daraprim — the drug at the center of a price-gouging controversy that earned him the “Pharma Bro” nickname — from generic rivals.

Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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