In the sto­ry law­mak­ers and drug pric­ing re­form ad­vo­cates have told about the drug in­dus­try, there are per­haps few greater vil­lains than Hu­mi­ra and its mak­er Ab­b­Vie.

Eliz­a­beth War­ren 

Be­tween 2012 and 2018, Ab­b­Vie upped the drug’s an­nu­al af­ter-re­bates cost from $19,000 to $38,000 in the US, with stick­er prices now over $60,000 per year — in­creas­es that led to ac­cu­sa­tions of price goug­ing, most re­cent­ly from De­mo­c­ra­t­ic pres­i­den­tial fron­trun­ner Eliz­a­beth War­ren.

“Hu­mi­ra is used by mil­lions of pa­tients around the world to treat dis­eases like arthri­tis, pso­ri­a­sis, and Crohn’s dis­ease,” War­ren tweet­ed Sat­ur­day as part of a thread on drug prices. “But its man­u­fac­tur­er, Ab­b­Vie, dou­bled its price—and used bla­tant­ly an­ti-com­pet­i­tive be­hav­ior to pre­vent a com­peti­tor from en­ter­ing the mar­ket.”

But mas­sive drug pric­ing bill or not, that re­al­i­ty will change in 2023 when sev­er­al biosim­i­lars are set to come to mar­ket. An­oth­er one just of­fi­cial­ly joined the list as Pfiz­er earned the FDA nod for its biosim­i­lar, ABRI­LA­DA.

Along with sev­er­al oth­er com­pa­nies, Pfiz­er was sued by Ab­b­Vie as the old Amer­i­can phar­ma de­vel­oped their ri­val drug — a not un­com­mon move in the biosim­i­lar world. Pfiz­er set­tled last year. Like Am­gen, My­lan, Sam­sung Bioepis, San­doz, Fre­se­nius Kabi, and Mo­men­ta all did, they agreed to roll out their biosim­i­lar in 2023.

At the time Boehringer In­gel­heim was the last hold­out, telling The Cen­ter for Biosim­i­lars “we are com­mit­ted to mak­ing it avail­able to US pa­tients as soon as pos­si­ble, and cer­tain­ly be­fore 2023.” They signed an agree­ment in May to re­lease their drug, Cyl­te­zo, in 2023.

Pfiz­er billed the news as an op­por­tu­ni­ty to help pa­tients in the long list of in­di­ca­tions that have made Hu­mi­ra a block­buster: rheuma­toid arthri­tis, ju­ve­nile id­io­path­ic arthri­tis, pso­ri­at­ic arthri­tis, anky­los­ing spondyli­tis, adult Crohn’s dis­ease, ul­cer­a­tive col­i­tis and plaque pso­ri­a­sis. The FDA tout­ed the move as the 25th ever biosim­i­lar ap­proval and the 9th this year.

The wide in­di­ca­tion has led to huge rev­enues for Ab­b­vie — $3.89 bil­lion in Q3 2019 alone — and im­proved qual­i­ty of life for many pa­tients, but the high prices have led to sto­ries of pa­tients stag­ger­ing dos­es to man­age the cost.

“Dur­ing the hol­i­days, I was con­tem­plat­ing what am I’m go­ing to do,” one 51-year-old woman with col­i­tis and Chron’s dis­ease told The New York Times last year. “I was think­ing should I just go on a liq­uid di­et, be­cause I can’t af­ford this.”

Com­pe­ti­tion should send the prices down when the biosim­i­lars roll­out. Eight are to be re­leased that year un­der set­tle­ments with Ab­b­Vie, be­gin­ning with Am­gen’s Am­je­vi­ta on Jan­u­ary 31st. Not all have been FDA ap­proved yet.

Pfiz­er will be the last to join the par­ty, with their roll­out date sched­uled for No­vem­ber 20, 2023. They have yet to gain EMA ap­proval but can mar­ket the drug in Eu­rope the mo­ment they pass that hur­dle.

Ab­b­Vie, though, is not yet out of the woods. Short­ly af­ter Boehringer set­tled the last of the in­tel­lec­tu­al prop­er­ty rights cas­es, a class ac­tion suit was lodged al­leg­ing Ab­b­Vie used its “patent thick­et” to cre­ate an il­le­gal mo­nop­oly and that Ab­b­Vie col­lud­ed with the biosim­i­lar com­peti­tors to di­vide the mar­ket.

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.