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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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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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%.

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New biotech newsletter launching this Thursday. Don’t miss out.

Hello, everyone. Damian here with a look at a pivotal FDA approval, good news for a small biotech company, and why not all buyouts are worth writing home about.

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AbbVie is acquiring Landos Biopharma, whose lead drug is a small molecule that takes a novel approach to treating ulcerative colitis. Preliminary proof-of-concept data from a Phase 2 study are expected later this year.

Editor’s note: A recording of the event is embedded below.

Several biosimilar versions of Humira, which for years has been the world’s best-selling medicine, entered the U.S. market over the past year. What has that meant for insurance coverage and the way drugmakers are marketing these medicines? Join leading experts to discuss the impact on the industry and patients.

Sponsor introduction

• Thomas Newcomer, vice president and head of U.S. market access, Samsung Bioepis (sponsor)

Featured speakers

• Chris M. Brown, president, McAteer
• Michael Gonzales, independent health care consultant, Michael Gonzales, LLC; former national and regional account director, AbbVie
• Fran Gregory, MBA, PharmD, vice president of emerging therapies, Cardinal Health
• Ed Silverman, Pharmalot columnist, senior writer, STAT (moderator)

Sponsored By

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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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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Hello! Today, we discuss how the FDA is holding firm in how it handles non-compliant trial sponsors and investigators, how PhRMA is rebuilding its ranks, and offer up a fabulous podcast.

The need-to-know this morning

• Advisers to the European Medicines Agency recommended the approval of Qalsody, a treatment for ALS from Biogen.

What do CEOs owe the world?

Did Humira break the system? And can you CRISPR a fetus? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.

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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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