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.

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

Bluebird bio announced it completed the rolling submission of its BLA to the FDA for betibeglogene autotemcel gene therapy.

The therapy, designed for patients with beta-thalassemia who require regular red blood cell transfusions, was previously granted breakthrough therapy designation for treating transfusion-dependent beta-thalassemia (TDT). If approved, beti-cel will be the first hematopoietic stem cell ex-vivo gene therapy for patients in the US.