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.

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

ViiV Healthcare and majority owner GlaxoSmithKline have cleared another important hurdle on a long-running quest to challenge Gilead’s dominance in preventative HIV treatments.

The final analysis of a new study shows the GSK subsidiary’s long-lasting injection, cabotegravir, proved 66% more effective in HIV prevention than Gilead’s breakthrough Truvada pill. And they now intend to carve away some of the blockbuster revenue that Gilead has enjoyed for years.

The pandemic stock market has proven fruitful for virtually any type of biotech. Now a 7-year-old cell therapy startup will see how much it can yield for a company that specializes in fighting viruses.

AlloVir, a company that until 2019 largely lived off grant money, has filed for a $100 million IPO to back its line of off-the-shelf, virus-fighting T cells. Although in normal circumstances, $100 million could be a solid return for a biotech that got its first major round of funding only last year, we’ll have to wait to see how much the company ultimately earns. As Covid-19 has sent investor money scurrying to almost anyone in drug development, every single biotech to go public this year has prized above their midpoint or upsized their offering, according to Renaissance Capital, sometimes dramatically so.