Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

House com­mit­tee to grill Ab­b­Vie CEO next month on sup­press­ing Hu­mi­ra com­pe­ti­tion

Ab­b­Vie CEO Richard Gon­za­lez will be in the hot seat on May 18, again de­fend­ing the com­pa­ny’s mam­moth block­buster drug Hu­mi­ra be­fore the House Over­sight Com­mit­tee as com­pe­ti­tion for the world’s best-sell­ing drug isn’t like­ly to hit Amer­i­can shores for about two years.

Over­sight Com­mit­tee Chair­woman Car­olyn Mal­oney (D-NY) has been ze­ro­ing in on Ab­b­Vie for months now, even threat­en­ing to is­sue a sub­poe­na last Sep­tem­ber for doc­u­ments as part of her com­mit­tee’s on­go­ing in­ves­ti­ga­tion in­to drug pric­ing prac­tices.

And with good rea­son. Ab­b­Vie’s cash cow Hu­mi­ra, which has brought in more than $90 bil­lion over the last five years, al­ready faces biosim­i­lar com­pe­ti­tion in the EU, but will not face such com­pe­ti­tion in the US un­til 2023.

In re­sults from the most re­cent quar­ter re­port­ed on Fri­day, Ab­b­Vie not­ed an al­most 7% in­crease in net rev­enues for Hu­mi­ra, de­spite a more than 8% de­cline in rev­enues in­ter­na­tion­al­ly.

Six Hu­mi­ra biosim­i­lars in the EU have made their mark, cap­tur­ing more than 50% mar­ket share in about two years, ac­cord­ing to a March re­port from Bern­stein biotech an­a­lyst Ron­ny Gal. The price for Hu­mi­ra in the EU has al­so dropped by more than 50% over that same time pe­ri­od, ac­cord­ing to Gal.

What re­mains to be seen is what this lat­est com­mit­tee in­ves­ti­ga­tion will ac­tu­al­ly do. Gon­za­lez pre­vi­ous­ly tes­ti­fied in 2019 be­fore the Sen­ate Fi­nance Com­mit­tee, not­ing, “We think we have struck a rea­son­able bal­ance” on Hu­mi­ra with the 2023 launch dates for biosim­i­lars, and say­ing the patent thick­ets to pro­tect the com­pa­ny’s mo­nop­oly were jus­ti­fied. “Well, re­mem­ber Hu­mi­ra is like nine dif­fer­ent drugs, 10 dif­fer­ent drugs,” he said.

Mal­oney tes­ti­fied be­fore a dif­fer­ent House sub­com­mit­tee on Thurs­day, not­ing that her com­mit­tee now has pre­vi­ous­ly non­pub­lic in­ter­nal doc­u­ments that show how Ab­b­Vie’s tac­tics sup­pressed com­pe­ti­tion for Hu­mi­ra and oth­er drugs and main­tained mo­nop­oly pric­ing in the US.

But ex­perts who spoke anony­mous­ly with End­points News didn’t think there was a good chance that any­thing would change be­fore 2023, un­less the Fed­er­al Trade Com­mis­sion took on Ab­b­Vie or if Ab­b­Vie ex­ec­u­tives were in­dict­ed.

Cit­i­zen Pe­ti­tion

Sep­a­rate­ly, Boehringer In­gel­heim, one of the com­pa­nies ex­pect­ing to bring a Hu­mi­ra biosim­i­lar to mar­ket in 2023, held a meet­ing last month to dis­cuss a cit­i­zen pe­ti­tion that rais­es con­cerns with the FDA about its in­ter­pre­ta­tion of the biosim­i­lars law with re­gard to in­ter­change­able biosim­i­lars.

Boehringer is one of the few com­pa­nies to pub­licly dis­close that it’s work­ing on an in­ter­change­able biosim­i­lar for Hu­mi­ra.

“BI main­tained that FDA’s cur­rent in­ter­pre­ta­tion of the statu­to­ry term ‘strength’ pro­vides an op­por­tu­ni­ty for ref­er­ence prod­uct ap­pli­ca­tion hold­ers to game the sys­tem through ‘prod­uct-hop­ping,’ which BI de­scribed as con­vert­ing pa­tients to a new con­cen­tra­tion of the brand­ed prod­uct and with­draw­ing the ex­ist­ing con­cen­tra­tion pri­or to the en­try of com­pet­ing biosim­i­lars,” ac­cord­ing to a sum­ma­ry of the meet­ing.

The com­pa­ny al­so said that FDA’s in­ter­pre­ta­tion of “strength” fa­cil­i­tates an­ti­com­pet­i­tive ever­green­ing tac­tics, and as­sert­ed that such types of ever­green­ing tac­tics would not be pos­si­ble if strength is in­ter­pret­ed in the law to mean to­tal drug con­tent with­out re­gard to con­cen­tra­tion.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

Pascal Soriot, AstraZeneca CEO (AP Images)

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19. However, follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.