Revelations that AbbVie, the manufacturer of Humira, made more than $100 billion in extra profits by abusing the patent system to delay generic competition has spurred efforts by the Biden administration and Congress to limit the length of patent monopolies over prescription drugs.

An executive order issued in July 2021 forced the Food and Drug Administration and the U.S. Patent and Trademark Office to join forces to finding ways to reduce the number of poor-quality patents that are granted. And the Senate’s Judiciary Committee reported out five bipartisan bills addressing competitive abuses that delay generic competition or otherwise lead to higher prescription drug prices.

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AbbVie and Capsida Therapeutics are expanding their gene therapy R&D alliance to the eyes. Capsida is in line to receive $70 million now and up to $595 million later, depending on the progress of the eye programs.

Meanwhile, do keep us in mind if you hear anything saucy. Our in-basket has been outfitted to accept postcards and telegrams. Have a smashing day. …

Eli Lilly says that all doses of its new Mounjaro diabetes drug are now available after social-media enthusiasm about weight-loss benefits sparked a two-month-long shortage, Bloomberg News tells us. The drug was approved in the U.S. last May to help people with type 2 diabetes control their blood sugar levels. Mounjaro is part of a group of diabetes treatments known as GLP-1s that have shown outsize potential for weight loss. Some of the drugs, including Mounjaro, are being recommended by doctors for weight loss even though they have not been explicitly approved as an obesity treatment in a common practice known as off-label prescribing.

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In making its case, the Pharmaceutical Accountability Foundation argued AbbVie allegedly overcharged the Dutch health care system by up to $1.2 billion by “abusing” its position in the marketplace and keeping prices high. The company sold approximately $2.3 billion worth of Humira in the Netherlands between 2004 and 2018, when its patents provided a monopoly.

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Humira has been the world’s best-selling medicine since it arrived on the market in 2002. Now, it is finally getting competition with the release of Amgen’s biosimilar drug, Amjevita. Humira’s main patent expired in 2016, but a byzantine patent saga has kept other drugmakers from offering their own version of the monoclonal antibody used to treat conditions such as rheumatoid arthritis and Crohn’s disease.

In this video, STAT senior writer and Pharmalot columnist Ed Silverman breaks down the convoluted world of pharmacy benefit managers, formularies, and a legal maneuver called “patent thicketing” that controls how much patients pay for this beneficial treatment.

Although gray skies are hovering over the Pharmalot campus, our spirits remain sunny because, as the Morning Mayor taught us, “Every brand new day should be unwrapped like a precious gift.” And so, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is salted caramel mocha. And you? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits. Hope you conquer the world, and do keep us in mind when you see something fascinating. …

Pharmaceutical executives are ready to make deals, The Wall Street Journal says. Executives at Pfizer, Merck, and Novartis are looking for promising drugs to add to their pipelines and replenish sales as top-selling products lose patent protection in the coming years. Meanwhile, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. The acquisitions could help the companies add new sales to aging line-ups and suggest this year could be a busy one for industry dealmaking. The $88 billion in total deal value last year, involving 75 biopharma tie-ups of at least $100 million, was the lowest since 2017, according to Ernst & Young.

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So to give it a nudge in a useful direction, we are firing up the coffee kettle to brew another cup of stimulation. Our choice today is maple bourbon. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits to help you start your journey. We hope your day is productive and meaningful. And of course, do keep in touch. We are searching for new pen pals …

Now that its blockbuster immune-disease therapy Humira is facing lower-priced competition, AbbVie is turning to a pair of next-generation successors to replenish the billions of dollars in sales that will be lost, The Wall Street Journal writes. The company is also betting on four drug approvals by the end of next year. In addition, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. AbbVie is counting most on persuading doctors that two newer immune drugs, Skyrizi and Rinvoq, are more effective than Humira and can pass peak Humira sales in four years.

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Underscoring the opaque and confusing nature of pharmaceutical pricing, Amgen announced long-awaited discounts for its biosimilar version of Humira — the world’s best-selling medicine — and the numbers suggest the biggest winners may be health insurers and others in the supply chain, but not patients.

Here’s why: The drug company will offer its medication, called Amjevita, at two different discounts — 5% and 55% — off the roughly $80,000 wholesale, or list, price. The maneuver reflects the behind-the-scenes negotiations that occur between pharmaceutical companies and the pharmacy benefit managers, or PBMs, that create formularies, or lists of medicines for which insurance coverage is provided.

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For years, Humira dominated the market for treating rheumatoid arthritis and other autoimmune disorders. In the process, it became the best-selling medicine in the world and generated billions of dollars in annual sales for AbbVie, which extended its monopoly time and again by filing dozens of patents that made it harder for would-be rivals to launch lower-cost biosimilar versions.

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Our choice today is Jack Daniels (yes, this is a real thing) in honor of our 16th anniversary since Pharmalot debuted. We would like to take a moment to thank you for tuning in all these years and, moreover, lift our cup to recognize those of you who provide feedback, suggestions, criticism, and tips. Now, though, time to get cracking once again. We hope your day is productive and meaningful. And of course, do stay in touch. …

After mobilizing to quickly develop and manufacture a Covid-19 vaccine, Johnson & Johnson has vastly scaled back efforts to produce the shots as it faces slumping demand, The Wall Street Journal reports. In recent months, J&J terminated manufacturing agreements with companies that helped produce the shot, such as Catalent and Sanofi. Meanwhile, a partnership with Merck to help make the shots, forged at the urging of the U.S. government, has not lived up to expectations. The companies are now engaged in arbitration. Merck made J&J vaccines at only one plant, but did not make commercial doses at another plant involved a more complex part of the manufacturing process.

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