STAT

STAT+: Thanks to CVS, a biosimilar version of AbbVie’s Humira is grabbing huge market share

The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market.

The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell any number of biosimilar medicines in the U.S.

This connection is crucial to the sudden jump in Hyrimoz prescriptions. How so? On April 1, CVS Caremark, which is one of the largest pharmacy benefit managers in the U.S., removed Humira from its major national formularies for health plans that cover about 30 million lives. Then, Hyrimoz was added to the formularies, which are the lists of medicines that are covered by health insurance.

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11 months 4 weeks ago

Pharma, Pharmalot, AbbVie, Biosimilars, drug pricing, STAT+

STAT

STAT+: Pharmalittle: We’re reading about Boehringer biosimilar frustrations, FTC warnings, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we expect to catch up on our reading, promenade extensively with our official mascots, and hold another listening party with Mrs. Pharmalot.

The rotation will likely include this, this, this, this and this. And what about you? If it is true that spring has sprung — and we are still awaiting definitive evidence — you might want to enjoy the great outdoors and watch the trees and flowers slowly come to life. If huddling inside your castle is preferable, there is always the option of staring at the telly and binge-watching a few things. Or if you prefer old-fashioned contact sports, reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Boehringer Ingelheim will lay off an undisclosed number of sales reps due to poor U.S. sales of its biosimilar version of AbbVie’s blockbuster arthritis treatment Humira, STAT reports. The drugmaker will switch to a hybrid model that mixes in-person and virtual sales by June 30, in large part because pharmacy benefit managers kept Humira on their formularies. That led to less uptake of biosimilar versions of Humira in the U.S., including Boehringer’s Cyltezo. Boehringer launched Cyltezo last July but has only managed to sell 1,487 prescriptions, according to IQVIA data. Almost 2.8 million Humira prescriptions have been written during that time.

An unprecedented crisis looms in India over supplies of injectable poliomyelitis vaccine, or IPV — a crucial tool in efforts to eradicate polio — now that Sanofi has shut its manufacturing plants in the country, The Economic Times reports. Sanofi, which is a leading supplier of the vaccine, ceased production of its IPV vaccine in December 2023, triggering concerns among health experts about an imminent supply disruption that may hobble the country’s most ambitious immunization campaign. IPV is made by only two companies — Sanofi Pasteur and Serum Institute of India, which started its supplies in 2021. Sanofi is believed to cater to over 80% of India’s IPV dose requirements.

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1 year 5 days ago

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STAT

STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market

WASHINGTON — Boehringer Ingelheim is laying off or relocating its sales staff for its Humira biosimilar Cyltezo in a sign of how difficult it’s been to get drug middlemen to adopt less-expensive versions of the blockbuster, the company confirmed. Some employees may find positions elsewhere in the company, but they are mostly being pulled from the field.

After two decades on the U.S. market, Humira (adalimumab) last year began facing competition from multiple less-expensive biosimilar versions of the blockbuster therapy. Cyltezo is one of the only biosimilars that can be substituted for Humira at the pharmacy counter without a doctor’s permission, so it is in a better competitive position than most others. 

The price of Humira rose 470% in the 20 years following its launch in 2003 to reach upward of $84,000 annually. List prices of Humira biosimilars are as much as 85% lower

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1 year 5 days ago

Biotech, Exclusive, Pharma, Biosimilars, drug pricing, STAT+

STAT

STAT+: Pharmalittle: We’re reading about a European probe into vaccine talks; net drug prices falling, and more

Rise and shine, everyone, another busy day is on the way. We can tell because our inbox is overflowing with correspondence and interesting ideas, a sure sign that we will be fully engaged for hours to come. To cope, yes, we are firing up the trusty coffee kettle and brewing some cups of stimulation. Our choice today is blueberry muffin. And yes, you are invited to join us.

Meanwhile, here is the latest menu of tidbits for you to digest. We hope you have smashing day and conquer the world. And do keep in touch. We enjoy the missives very much. …

Top European prosecutors are investigating allegations of criminal wrongdoing in connection with vaccine negotiations between European Commission President Ursula von der Leyen and the Pfizer chief executive officer, Politico reports. Investigators from the European Public Prosecutor’s Office have in recent months taken over from Belgian prosecutors investigating von der Leyen over “interference in public functions, destruction of SMS, corruption and conflict of interest.” No one has yet been charged in connection with the case. The probe was originally opened by Belgian judicial authorities in early 2023 after a criminal complaint was lodged by a local lobbyist.

The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year’s fourth quarter, STAT writes, adding this is the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends. A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis from biosimilar versions of the medicine. The Humira net price fell to roughly $29,800 at the end of last year from $48,000 at the end of 2022, a nearly 38% drop.

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1 year 1 week ago

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STAT

STAT+: As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’

The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceutical companies.

PBMs, the middlemen of drug pricing negotiations, also claim portions of those lucrative rebates for themselves. So when new market developments threaten to diminish or wipe away that revenue stream, PBMs find crafty ways to keep as much of those dollars as possible — often at the expense of employers.

One such case occurred last year, when a wave of Humira biosimilars entered the market and drug companies slashed the list prices of their insulin products. CVS Caremark, the PBM owned by CVS Health that oversees the prescription drug benefits of 103 million people, told its employer clients that it anticipated “more lower-cost products (including specialty biosimilars) may become preferred products” on its lists of approved drugs for 2024, according to documents obtained by STAT.

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1 year 3 weeks ago

Business, Exclusive, health insurance, life sciences, PBMs, Pharmaceuticals, STAT+

STAT

STAT+: Biden’s SOTU highlights pharma’s biggest political problem: It is terrifyingly, awfully alone

If you’re a drug company executive, you probably feel like you got up on the wrong side of bed.

On Thursday night, President Biden proposed expanding one of his most popular policies: the Medicare price negotiation process that was put in place as part of the Inflation Reduction Act. “Americans pay more for prescription drugs than anywhere else,” Biden said. “It’s wrong and I’m ending it.”

Obviously, the drug industry is not going to be happy about new price limitations in the U.S., the biggest market for pharmaceuticals. But, even more than that, Biden’s move emphasizes a painful reality: That pharmaceutical companies remain one of the biggest political targets in the country — despite their key role in addressing the Covid-19 pandemic and their development of wildly effective new weight loss drugs.

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1 year 1 month ago

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STAT

STAT+: Up and down the ladder: The latest comings and goings

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that KaliVir Immunotherapeutics hired James Burke as chief medical officer. Previously, he worked at CG Oncology, where he was also chief medical officer.

But all work and no play can make for a dull chief medical officer.

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1 year 1 month ago

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STAT

STAT+: Pharmalittle: We’re reading about a CEO change at AbbVie, a long-acting HIV drug, and more

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is strawberry creme — and get started. To help you along, we have assembled another menu of tidbits for you to peruse.

Meanwhile, do keep us in mind if you hear anything interesting. We continue to accept — at absolutely no charge to you — postcards and telegrams. And of course, we hope you have a smashing day. …

AbbVie announced that chief executive officer Richard Gonzalez, who has managed its ascent since being spun off from Abbott Laboratories in 2013, will step down in July, STAT notes. Gonzalez previously said he would depart when AbbVie had a plan in place to move on from its best-selling drug, Humira, which is now facing competition from cheaper biosimilars. He will be replaced by chief operating officer Robert Michael, who, like Gonzalez, is a longtime AbbVie executive. Worth noting: Gonzalez, 70, who will become executive chairman of the board of directors, should be a sobering reminder to pharmaceutical industry critics of the resilience of a chief executive officer’s reputation.

Three conservative-led states — Idaho, Kansas and Missouri — lost their bid to intervene in a battle between the Biden administration and conservative physicians over the abortion pill mifepristone, Bloomberg Law writes. The U.S. Supreme Court decision comes ahead of March 26 oral arguments in the case and marks a victory for the Biden administration in defending U.S. Food and Drug Administration safety decisions on the drug that previously were struck down by an appeals court. The state intervention motion was tailored to maintain the litigation should the Supreme Court find that the conservative physicians lacked standing to sue the FDA over its decisions on the pill.

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1 year 1 month ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: AbbVie CEO Gonzalez to step down after a decade fiercely defending its top seller, Humira

AbbVie announced Tuesday that CEO Richard Gonzalez, who has managed the company’s ascent since it was spun off from the device maker Abbott Laboratories in 2013, will step down in July.

Gonzalez had previously said he would depart when AbbVie had a plan in place to move on from its best-selling drug, Humira, which is now facing competition from cheaper biosimilars.

He will be replaced by Chief Operating Officer Robert Michael, who, like Gonzalez, is a longtime AbbVie executive. Gonzalez, 70, will become executive chairman of the board of directors.

Gonzalez should be a sobering reminder to the drug industry’s critics of how resilient a CEO’s reputation can be. Because while he has been a subject of nearly constant criticism for AbbVie’s handling of Humira and the patents protecting it, investors are likely to remember him fondly.

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1 year 1 month ago

Biotech, Pharma, AbbVie, biotechnology, patents, Pharmaceuticals, STAT+

STAT

STAT+: Lasers, cardiology, clinical trials: 2023’s top private equity targets

By some measures, private equity investment lagged in 2023, a year marked by growing distress and high-profile downfalls among private equity-backed health care companies.

By some measures, private equity investment lagged in 2023, a year marked by growing distress and high-profile downfalls among private equity-backed health care companies.

Even so, three sectors still managed to see strong deal flow and prices: med spa, cardiology, and clinical trial sites, according to a new PitchBook report analyzing private equity investments in health care services in 2023. Each of the three niches continue to generate buzz among investors, even as other areas fizzle.

It’s not that those three industries are perfect fits for private equity, it’s that the more obvious areas like autism therapists and physician practices are struggling with high interest rates and regulatory scrutiny, said Rebecca Springer, PitchBook’s lead health care analyst.

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1 year 2 months ago

Business, Health, Insurance, cardiovascular disease, Clinical Trials, finance, Hospitals, physicians, policy, private equity, STAT+

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