Ab­b­Vie digs in for a long war as Am­gen bags first OK for a Hu­mi­ra biosim­i­lar

The FDA pro­vid­ed its stamp of ap­proval on Am­gen’s biosim­i­lar of Ab­b­Vie’s an­ti-in­flam­ma­to­ry megablock­buster Hu­mi­ra. But don’t look for any cheap­er copies of the drug any­time soon. Ab­b­Vie plans to fight to the last lawyer keep­ing the com­peti­tor off the mar­ket, claim­ing it has patents in place to bar this and oth­er ri­vals in the works for an­oth­er six years.

Janet Wood­cock

Ab­b­Vie has plen­ty to gain and much to lose when it comes to Hu­mi­ra and the biosim­i­lar mar­ket. The com­pa­ny earned about $14 bil­lion off the one fran­chise last year, and the num­bers keep head­ed north. In the sec­ond quar­ter, its flag­ship drug brought in $4.15 bil­lion. Hu­mi­ra pro­vides rough­ly two thirds of its rev­enue and Ab­b­Vie has been fight­ing for more time — lots more time — to de­vel­op new drugs to take its place.

Am­gen, mean­while, will be push­ing to get their copy­cat — named Am­je­vi­ta — on the mar­ket some­time next year, hop­ing that once the main patent laps­es in De­cem­ber they can fight their way out front. Mean­while, Mer­ck/Sam­sung Bioepis, No­var­tis and Shire (Bax­al­ta)/Mo­men­ta al­so have knock­offs in the clin­ic, look­ing to line up for a share of the mar­ket as well.

The slate of new ap­provals on biosim­i­lars, with one un­ex­plained re­jec­tion for No­var­tis, has helped il­lu­mi­nate the FDA’s at­ti­tudes to­ward biosim­i­lars. Clean da­ta on one cen­tral in­di­ca­tion ap­pears good enough to win ap­provals for a full slate of in­di­ca­tions. And the agency ap­pears ready to move quick and fast to green light these drugs, even if patent bat­tles are like­ly to take much longer to play out.

Am­gen, for ex­am­ple, has been play­ing de­fense on the biosim­i­lars front as well as of­fense. The com­pa­ny has been fight­ing a de­lay­ing ac­tion against No­var­tis’ ap­proved ri­val Zarxio, a copy of ne­u­pogen.

“This is the fourth FDA-ap­proved biosim­i­lar. The biosim­i­lar path­way is still a new fron­tier and one that we ex­pect will en­hance ac­cess to treat­ment for pa­tients with se­ri­ous med­ical con­di­tions,” said Janet Wood­cock, M.D., di­rec­tor of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Publicis Groupe CEO Arthur Sadoun (L) is joined by actor Michael Douglas in a holiday message encouraging HPV vaccination (Publicis Groupe/YouTube)

Pub­li­cis for­goes light­heart­ed hol­i­day mes­sage for more se­ri­ous HPV warn­ing with celebri­ty guest

When is an annual holiday greeting more like a disease awareness ad? That’s the case in this year’s video from French-based advertising holding company Publicis Groupe featuring chairman and CEO Arthur Sadoun and his predecessor Maurice Lévy.

The typically jovial interaction between the two quickly takes a serious turn to HPV cancers and vaccines — along with a guest star appearance by actor Michael Douglas.

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