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.

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.

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.

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.

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.