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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1 year 1 day 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 1 week ago

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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 2 weeks ago

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STAT

STAT+: Net prices for medicines fell considerably in 2023’s last quarter, mostly thanks to Humira biosimilars

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, 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. Over the past year, nine biosimilar versions of the medicine were launched by other companies seeking favorable placement on formularies, the lists of drugs for which health insurance coverage is available.

As these companies battled to win placement, 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, the SSR analysis found. In fact, the entire category of rheumatoid arthritis medicines saw a 30% decline in annual net pricing, the largest such drop among all type of drugs. Meanwhile, net prices for psoriasis treatments fell nearly 10%.

Continue to STAT+ to read the full story…

1 year 2 weeks ago

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STAT

STAT+: Pharmalittle: We’re reading about state moves on drug pricing, an asthma med for kids and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because — you know what we are going to say — that oh-so familiar routine of online meetings, endless calls and deadlines has returned. But what can you do? The world, such as it is, continues to spin.

So let us be optimistic and convince ourselves we can nudge it in a better direction with a cup of stimulation. Our choice today is cinnamon vanilla, which we recently procured. Please feel free to join us. Meanwhile, here are a few tidbits to help you get started. We hope you have a smashing day and conquer the world…

A drug that has been used for decades to treat allergic asthma and hives significantly reduced the risk of life-threatening reactions in children with severe food allergies who were exposed to trace amounts of peanuts, cashews, milk and eggs, The New York Times writes, citing newly published research. The drug, Xolair, has already been approved by the U.S. Food and Drug Administration for adults and children over age 1 with food allergies. This is the first treatment that drastically cuts the risk of serious reactions — like anaphylaxis, a life-threatening allergic reaction that causes the body to go into shock — after accidental exposures to various food allergens.

Colorado is pioneering a new way for states to crack down on prescription drug costs, STAT reports. In a first-in-the-nation move, a state board voted to create a payment limit for a widely prescribed Amgen drug used to treat arthritis, a step that may usher in a new era in which state governments take more aggressive action to control the cost of prescription medicines. The drug, called Enbrel, costs insurers an average of $46,772 per patient per year, according to 2022 data from the state’s all-payer claims database. The state board evaluated two other drugs so far, but Enbrel was the first the board deemed unaffordable for Colorado patients.

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1 year 1 month ago

Pharma, Pharmalot, Uncategorized

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.

Continue to STAT+ to read the full story…

1 year 1 month ago

Pharma, Pharmalot, biotechnology, life sciences, Pharmaceuticals, STAT+

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

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STAT

STAT+: Diabetes treatments have improperly listed patents that should be removed, analysis finds

More than half of the injector-pen patents for several widely used diabetes treatments — including Ozempic and Mounjaro — do not mention several important characteristics that should otherwise prevent them from being listed in a key federal registry, according to a new analysis.

As a result, the researchers contend the patents may be unfairly used to preclude competition from companies that may want to market lower-cost generic products. They also suggest antitrust regulators may want to widen a probe into improperly filed patents for asthma inhalers and epinephrine injectors to include drug-and-device combination products for combating diabetes.

A total of 188 patents were examined for 10 combination products that include a delivery device and a medicine known as a GLP-1. Among the products reviewed was Eli Lilly’s Mounjaro and Novo Nordisk’s Ozempic. Patents for another Novo Nordisk treatment, Wegovy, were also reviewed since it contains the same key ingredient as Ozempic, even though it is approved only for weight loss.

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1 year 2 months ago

Pharma, Pharmalot, biotechnology, Obesity, patents, STAT+

STAT

STAT+: Pharmalittle: We’re reading about Sanders targeting pharma CEOs, insider trading, 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. Given the forecast, our agenda is modest. We expect to catch up on our reading, take a few naps, and promenade with the official mascots as often as possible. We also plan another listening party with Mrs.

Pharmalot, and the rotation will likely include this, this, this, and this. And what about you? This is a fine time to enjoy the great indoors. So why not tidy up around your castle? When done, you could park yourself in front of the telly and watch a few moving picture shows. Of if you’re feeling old fashioned, you could pull out the Scrabble board. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

U.S. Senate health committee chair Bernie Sanders has taken a step toward subpoenaing the chief executive officers at Johnson & Johnson and Merck related to an investigation into high drug prices in the U.S., STAT writes. The step is highly unusual, since the health committee has not issued a subpoena in more than 40 years. Sanders (I-Vt.) invited the J&J and Merck executives, along with Bristol Myers Squibb chief executive officer Chris Boerner, to testify at a Jan. 25 hearing. But only Boerner agreed, and only if at least one other chief executive participated. Instead, Sanders will hold a committee vote on whether to issue the subpoenas and authorize a probe into drug costs on Jan. 31.

But Johnson & Johnson is accusing Sanders of retaliating against the company and others that sued the Biden administration to stop a program to negotiate how much Medicare pays for high-cost drugs, Bloomberg Law reports. The allegation appears in a letter that was written one week before Sanders announced the Senate health committee would vote on whether it would use subpoenas to force J&J and Merck CEOs to testify on U.S. drug prices. The committee’s actions raise “significant concerns that the hearing is intended as retribution” against companies suing the Biden administration over the Medicare negotiation program, the letter says.

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1 year 2 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Klobuchar urges drugmakers to remove patents FTC calls improper and inaccurate

Amid a push to crack down on patent abuse by the pharmaceutical industry, a key U.S. lawmaker is urging six large drug companies to remove dozens of patents that were identified by regulators as improperly or inaccurately listed with a federal registry.

In a series of letters sent on Thursday, Sen. Amy Klobuchar (D-Minn.) demanded the companies explain why they have, so far, not responded to warnings issued two months ago by the Federal Trade Commission to remove more than 100 patents from the registry. The agency threatened the drug companies with litigation if they failed to comply.

The FTC had challenged a total of 10 companies over listings for patents on such medicines as asthma inhalers and epinephrine auto-injectors as part of an effort to mitigate actions that thwart competition. Among the companies to which the agency sent warnings are AbbVie, AstraZeneca, Mylan Specialty, Boehringer Ingelheim, and subsidiaries of GSK and Teva Pharmaceutical.

Continue to STAT+ to read the full story…

1 year 2 months ago

Pharma, Pharmalot, patents, Pharmaceuticals, STAT+

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