Two years be­fore the first biosim­i­lars to megablock­buster Hu­mi­ra are ex­pect­ed to hit the US mar­ket, Ab­b­Vie is tak­ing one de­vel­op­er to court over al­le­ga­tions it stole trade se­crets to cre­ate its copy­cat ver­sion.

Ab­b­Vie has filed suit against Ice­landic biotech Alvotech for “in­junc­tive re­lief and re­cov­ery of dam­ages,” ac­cord­ing to court doc­u­ments dat­ed Fri­day. The phar­ma ac­cus­es Alvotech of em­bark­ing on an “un­law­ful plot to sur­rep­ti­tious­ly take Ab­b­Vie’s con­fi­den­tial and pro­pri­etary trade se­crets.”

The al­leged scheme re­volves around the hir­ing of Rongzan Ho, a for­mer Ab­b­Vie team leader of Hu­mi­ra’s up­stream man­u­fac­tur­ing. In its com­plaint, Ab­b­Vie says Ho at­tempt­ed three times to email “trade se­cret in­for­ma­tion” about the large-scale man­u­fac­tur­ing of Hu­mi­ra to his per­son­al ac­count be­fore leav­ing the com­pa­ny for Alvotech. The first two tries were blocked by the com­pa­ny’s se­cu­ri­ty sys­tem, Ab­b­Vie al­leges. But the third — an email ti­tled “Keep in touch (Ab­b­Vie)” — was suc­cess­ful, ac­cord­ing to the court doc­u­ments.

Ab­b­Vie says Ho “af­fir­ma­tive­ly mis­rep­re­sent­ed” that he had ex­punged all Ab­b­Vie in­for­ma­tion from any de­vices, in­clud­ing his com­put­er, ex­ter­nal stor­age de­vice, email or cloud stor­age up­on leav­ing the job.

The com­pa­ny al­so ac­cused Alvotech of con­tin­u­ing to re­cruit Ab­b­Vie em­ploy­ees with “in­ti­mate knowl­edge” of Hu­mi­ra’s man­u­fac­tur­ing process, adding that two ad­di­tion­al staffers were hired last May.

“Un­less en­joined, Alvotech’s il­le­gal ac­tions will serve as a roadmap to use Ab­b­Vie’s trade se­crets for both Alvotech and oth­er com­pa­nies that have not ad­e­quate­ly in­vest­ed in their own in­de­pen­dent re­search and de­vel­op­ment,” the com­plaint reads.

Alvotech wrote in an email to End­points News that it “strong­ly dis­putes” the al­le­ga­tions, adding it’s been three years since the “pur­port­ed date of the al­leged wrong­do­ing,” and the em­ploy­ee in ques­tion no longer works for Alvotech.

“Alvotech will vig­or­ous­ly de­fend against these al­le­ga­tions,” a spokesper­son said.

A host of crit­ics, in­clud­ing US law­mak­ers, have called Ab­b­Vie out in the past for its patent-ag­gres­sive ap­proach with Hu­mi­ra. This past June, a US judge ruled in fa­vor of Ab­b­Vie against al­le­ga­tions that it en­gaged in an­ti­com­pet­i­tive con­duct to el­bow out ri­vals.

When Ab­b­Vie’s main patent for Hu­mi­ra ran out in 2016, the com­pa­ny ap­plied for a raft of new patents — a move that was fur­ther strength­ened by agree­ments with Am­gen, Sam­sung Bioepis, and No­var­tis’ San­doz to keep biosim­i­lars off the US mar­ket un­til 2023, that com­plaint said.

Back in Au­gust, Ab­b­Vie paid $24 mil­lion to set­tle a law­suit brought forth by Cal­i­for­nia’s in­sur­ance reg­u­la­tor, al­leg­ing that Ab­b­Vie bribed and re­ward­ed physi­cians for Hu­mi­ra pre­scrip­tions. While Ab­b­Vie de­nied the claims, it agreed to look in­to how Hu­mi­ra is mar­ket­ed in the state, ac­cord­ing to a Reuters re­port. 

With the clock tick­ing on Hu­mi­ra, Ab­b­Vie has start­ed mak­ing the case for its new­er meds. Back in Jan­u­ary, the com­pa­ny read out new Phase III da­ta for its IL-23 Skyrizi, which showed the drug beat a place­bo at re­duc­ing pso­ri­at­ic arthri­tis pa­tients’ symp­toms from base­line af­ter six months of treat­ment.

Re­ports sur­faced ear­li­er this month that Ab­b­Vie is al­so con­sid­er­ing sell­ing off the $5 bil­lion women’s health port­fo­lio it ac­quired from Al­ler­gan, in or­der to pay off debt and fo­cus on new ar­eas.

Un­named sources told Reuters that Ab­b­Vie was work­ing with Mor­gan Stan­ley to auc­tion off the port­fo­lio, which in­cludes the Lo Loestrin Fe birth con­trol pill. But when End­points News reached out for con­fir­ma­tion, a spokesper­son replied: “We don’t com­ment on ru­mors.”

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.