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.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.