What can $1 bil­lion buy? If you’re Am­gen, it’s good for two man­u­fac­tur­ing fa­cil­i­ties in the US.

The Cal­i­for­nia-based drug gi­ant will in­vest close to $550 mil­lion in a drug sub­stance plant in Hol­ly Springs, NC, adding it­self to an ever-grow­ing list of biotech com­pa­nies that have de­cid­ed to call North Car­oli­na home, and mark­ing its sec­ond drug man­u­fac­tur­ing an­nounce­ment in a lit­tle more than a month.

Am­gen pre­vi­ous­ly an­nounced an ex­pan­sion in Ohio, along with an agree­ment with Ohio State Uni­ver­si­ty to cre­ate an ex­pe­ri­en­tial learn­ing pro­gram, to­ward the end of June. But the news of its Hol­ly Springs, NC in­vest­ment snuck in­to its Q2 earn­ings re­port Tues­day.

“In an­tic­i­pa­tion of fu­ture de­mand for our med­i­cines, we will in­vest ap­prox­i­mate­ly $1 bil­lion to build two new man­u­fac­tur­ing fa­cil­i­ties – a pack­ag­ing plant in Ohio and a drug sub­stance plant in North Car­oli­na,” the re­lease said. “Both of these fa­cil­i­ties will be built faster and at a low­er cost than tra­di­tion­al plants, and both al­so will uti­lize cut­ting-edge tech­nolo­gies to be more ef­fi­cient and en­vi­ron­men­tal­ly friend­ly than tra­di­tion­al plants.”

Am­gen did not re­spond to a re­quest for com­ment Wednes­day.

The North Car­oli­na fa­cil­i­ty will cre­ate more than 350 jobs and is set to be op­er­a­tional by 2025, the com­pa­ny said. Con­struc­tion will start in 2021 and be com­plet­ed by 2029, and new hires will in­clude en­gi­neers, tech­ni­cians, qual­i­ty, man­age­ment and ad­min­is­tra­tive roles.

In­cen­tives in­clude a job de­vel­op­ment grant from the state worth around $12.6 mil­lion, and an­oth­er $22.8 mil­lion in in­cen­tives from Wake Coun­ty and the Hol­ly Springs lo­cal gov­ern­ment. The grants are con­tin­gent up­on hir­ing and in­vest­ment mile­stones. The av­er­age salary of the new po­si­tions added is ex­pect­ed to reach near­ly $120,000, close to dou­ble what the cur­rent av­er­age is in Wake Coun­ty.

“World-class com­pa­nies like Am­gen are very se­lec­tive when they eval­u­ate busi­ness lo­ca­tions and they on­ly choose places that pro­vide the best sup­port for their op­er­a­tions,” Gov. Roy Coop­er said in a press re­lease. “To­day’s de­ci­sion proves once again that North Car­oli­na re­mains a pre­mier lo­ca­tion for the most in­no­v­a­tive biotech com­pa­nies in the in­dus­try.”

Fu­ji­film Diosynth joined the ex­pan­sion par­ty in Hol­ly Springs in March with the an­nounce­ment of a $2 bil­lion plant of its own. A month ear­li­er, Gilead opened an of­fice for fi­nance, IT and hu­man re­sources op­er­a­tions in the area.

Am­gen’s ex­pan­sion marks the 47th life sci­ences project to come to North Car­oli­na since 2017, Coop­er said in an event.

San­dra Ro­driguez-Tole­do

“Cam­bridge and Boston bet­ter look out be­cause North Car­oli­na is com­ing,” Coop­er said.

Robert Keny­on, Am­gen’s VP of man­u­fac­tur­ing, will be the site lead for the new fa­cil­i­ty. He told the N&O that Am­gen will be the first ten­ant in the Friend­ship In­no­va­tion Park and that the site will have sin­gle-use tech­nol­o­gy, which pro­vides flex­i­bil­i­ty to man­u­fac­ture dif­fer­ent drugs.

“We are ex­cit­ed to be mak­ing this in­vest­ment in Hol­ly Springs and be­com­ing an im­por­tant part of the com­mu­ni­ty,” Keny­on said in a re­lease. “Be­yond be­ing a vi­brant busi­ness en­vi­ron­ment, the area of­fers a skilled, trained, and di­verse tal­ent pool that we know will help Am­gen main­tain its long his­to­ry of serv­ing pa­tients.”

Am­gen is al­so in­vest­ing $365 mil­lion in­to a new man­u­fac­tur­ing plant in New Al­bany, OH, 18 miles north­east of Colum­bus, to fur­ther its as­sem­bly and pack­ag­ing ca­pa­bil­i­ties. That site will be 270,000 square feet, and be housed in the New Al­bany In­ter­na­tion­al Busi­ness Park. VP of site op­er­a­tions San­dra Ro­driguez-Tole­do will move from Puer­to Ri­co to Ohio to over­see the new fa­cil­i­ty.

An active pharmaceutical ingredient site in India has been handed a warning letter from the FDA, following an August 2021 inspection.

AuroLife Pharma’s Hyderabad site, which is part of the Aurobindo group of companies, was handed the letter in November. It’s the latest in a string of manufacturing woes the company has battled as of late.

Unit 1 of its Hyderabad site was inspected, and received an official action initiated notice from the FDA. “The company believes that this will not impact the existing business from this facility,” it said in a filing.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.