$21B or bust! Ab­b­Vie en­sures its block­buster US marathon on Hu­mi­ra will run in­to 2023

Ab­b­Vie has fin­ished an­oth­er big sec­tion in its great wall of pro­tec­tive IP deals that will keep the world’s biggest block­buster un­marked by biosim­i­lar com­pe­ti­tion in the US for 5 long years.

Lau­ra Schu­mach­er

Six months af­ter Ab­b­Vie struck a deal with Am­gen that al­lows a knock­off of Hu­mi­ra to hit US shores on Jan­u­ary 31, 2023, Sam­sung Bioepis and Mer­ck signed off on an agree­ment to un­veil their biosim­i­lar on June 30, 2023. In most coun­tries in the EU, though, the de­but will come this fall, on Oc­to­ber 16.

“We con­tin­ue to be­lieve biosim­i­lars will play an im­por­tant role in our health­care sys­tem, but we al­so be­lieve it is im­por­tant to pro­tect our in­vest­ment in in­no­va­tion,” not­ed Ab­b­Vie EVP and gen­er­al coun­sel Lau­ra Schu­mach­er. “This agree­ment ac­com­plish­es both ob­jec­tives.”

How im­por­tant is this for Ab­b­Vie?

The bio­phar­ma com­pa­ny has been fight­ing for time to get new drugs lined up for the mar­ket so it can re­place a drug that pro­vides the li­on’s share of its rev­enue. Ab­b­Vie earned more than $18 bil­lion from Hu­mi­ra last year, with the rev­enue ris­ing steadi­ly as it con­tin­ues to push through an­nu­al hikes in the price.

Richard Gon­za­lez

In its Q3 re­port last year the com­pa­ny re­port­ed that it now ex­pects to see Hu­mi­ra sales climb to close to $21 bil­lion in 2020. To put that in some per­spec­tive, CEO Rick Gon­za­lez had fore­cast peak sales at $18 bil­lion by 2020 less than two years ago. That $3 bil­lion in ex­tra sales rep­re­sents the kind of block­buster rev­enue most bio­phar­mas would be hap­py to see from any one of its drugs. And most of it was de­liv­ered by con­tro­ver­sial price in­creas­es.

The deal comes as US of­fi­cials are work­ing on a plan to strip away some of the de­fen­sive moves that big play­ers like J&J have used to keep biosim­i­lar com­pe­ti­tion at bay. That’s an­oth­er threat that Ab­b­Vie won’t have to fret about.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

Bio­phar­ma ramps up lob­by­ing spend as drug pric­ing leg­is­la­tion nears

The top biopharma companies in the world collectively spent more than $40 million in just the first quarter of 2021 on lobbying Congress as part of preparations to stave off major drug pricing legislation that’s expected later this year.

Although the numbers are not dramatically higher than what the companies collectively spent in the first quarter of 2020, some like GlaxoSmithKline, Teva, Merck and Johnson & Johnson have already increased their quarterly lobbying spend in 2021 by about $1 million more each when compared to recent quarters in 2020.

House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”