More biosim­i­lar use could've saved Medicare and ben­e­fi­cia­ries $84M in 2019, HHS OIG says

In the near­ly 7 years since biosim­i­lars were first ap­proved in the US, the sto­ry has been one of lack­lus­ter up­take, amid a grow­ing fa­mil­iar­i­ty with the way the patent “dance” works, and how the FDA ap­proval process plays out.

But the biosim­i­lar side of the bi­o­log­ics equa­tion is go­ing to need to car­ry more of the weight mov­ing for­ward as bi­o­log­ics are es­ti­mat­ed to cost CMS’ Part D pro­gram up­wards of $12 bil­lion an­nu­al­ly, and that num­ber has been go­ing up in re­cent years.

What’s more: much of this to­tal right now is spent on two bi­o­log­ics — Ab­b­Vie’s Hu­mi­ra and Am­gen’s En­brel ac­count­ed for more than $5 bil­lion in Part D spend­ing and near­ly half of Part D spend­ing on bi­o­log­ics in 2019 — even as biosim­i­lar com­pe­ti­tion for both drugs are al­ready FDA-ap­proved but will not be mar­ket­ed un­til next year in the case of Hu­mi­ra, and En­brel biosim­i­lars will wait un­til 2029.

In a new re­port re­leased ear­li­er this week, HHS’ Of­fice of the In­spec­tor Gen­er­al ex­plains how in 2019, when the biosim­i­lar US mar­ket was in its rel­a­tive in­fan­cy with just eight biosim­i­lars for four ref­er­ence prod­ucts cov­ered un­der Part D, brand-name bi­o­log­ics with biosim­i­lar com­pe­ti­tion were still be­ing pre­scribed about five times more fre­quent­ly than their biosim­i­lars in Part D.

“We es­ti­mat­ed that with in­creased use of biosim­i­lars in­stead of ref­er­ence prod­ucts, Part D and ben­e­fi­cia­ry spend­ing could have been con­sid­er­ably re­duced in 2019. Specif­i­cal­ly, Part D spend­ing on bi­o­log­ics with avail­able biosim­i­lars could have de­creased by $84 mil­lion, or 18 per­cent, if all biosim­i­lars had been used as fre­quent­ly as the most used biosim­i­lars,” the re­port says, ex­plain­ing:

Part D gross spend­ing on biosim­i­lars and their ref­er­ence prod­ucts could have de­creased $84 mil­lion in 2019 if all avail­able biosim­i­lars had been used at the same 60-per­cent uti­liza­tion rate as fil­gras­tim biosim­i­lars. This amounts to 18 per­cent of the $466 mil­lion that Part D spent on all biosim­i­lars and their ref­er­ence prod­ucts in 2019. We es­ti­mat­ed uti­liza­tion for all biosim­i­lars at 60 per­cent be­cause fil­gras­tim biosim­i­lars had achieved this uti­liza­tion rate af­ter near­ly 5 years on the mar­ket. Fur­ther­more, if biosim­i­lars had been used at a 90-per­cent uti­liza­tion rate—the uti­liza­tion rate of gener­ic, non­bi­o­log­ic drugs—Part D gross spend­ing on these drugs could have de­creased by $143 mil­lion, or 31 per­cent of ac­tu­al 2019 gross spend­ing.

Out-of-pock­et costs could have sim­i­lar­ly de­clined with the use of more biosim­i­lars by 12%, or $1.8 mil­lion.

“Al­though these amounts are mod­est in the con­text of over­all Part D spend­ing, far greater spend­ing re­duc­tions will be pos­si­ble as ad­di­tion­al biosim­i­lars be­come avail­able,” OIG says.

Cur­rent­ly, 32 biosim­i­lars have been ap­proved, and 21 have hit the mar­ket, with more com­ing soon.

As far as sug­ges­tions mov­ing for­ward, OIG calls on CMS to en­cour­age health plans to in­crease ac­cess to and use of biosim­i­lars in Part D, as well as to bet­ter mon­i­tor biosim­i­lar cov­er­age on for­mu­la­ries to iden­ti­fy “con­cern­ing trends.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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