The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.

Meanwhile, our ever-growing to-do list requires attention. Sound familiar? So, here are some items of interest. Have a great day and hope you conquer the world, everyone …

Coherus BioSciences agreed to resolve a dispute over its plans to launch a lower-priced version of AbbVie’s Humira rheumatoid arthritis drug, Reuters writes. Earlier this month, Coherus said it will launch a biosimilar version of the drug at an 85% discount to the $6,922 list price and partnered with Mark Cuban Cost Plus Drug Company to sell it at $569.27. AbbVie alleged it breached an older deal granting Coherus a non-exclusive license to commercialize a biosimilar version in the U.S. as of July 1. AbbVie will not terminate the initial licensing deal based on its notice. It would have to serve another notice and give Coherus time to resolve the breach if it chooses to end the deal.

Expanded access to the Alzheimer’s drug from Eisai and Biogen is unlikely to happen quickly even if the Food and Drug Administration decides follow-up studies confirm the drug helps slow the disease, Bloomberg News explains. Medicare said that “broader” coverage would begin “on the same day the FDA grants traditional approval.” But patients, doctors, and analysts are all doubtful, citing the limited information publicized by the agency on how the registry will work. For the registry to succeed, it must be easy for prescribers to use, they argue. Researchers and others also will need real-time data to show whether the drug is beneficial and safe, they added.

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The agreement  —which involves Teva Pharmaceuticals; Allergan, a unit of AbbVie; CVS; and Walgreens — is the latest involving several major players blamed for the crisis. Last year, dozens of states and thousands of local communities reached a global settlement worth $26 billion with three largest pharmaceutical wholesalers as well as Johnson & Johnson to resolve civil lawsuits.

As part of the deal, Teva agreed not to market opioids and will provide its generic version of Narcan, the overdose reversal medication, which it has valued at $1.2 billion. Allergan is required to stop selling opioids for the next 10 years, while CVS and Walgreens have agreed to monitor, report, and share data about suspicious activity related to opioid prescriptions.

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In the meantime, here as always are some tidbits to get your day started. If you hear anything interesting out there, do let us know. …

Coherus BioSciences plans to sell a biosimilar version of Humira at a steep discount, STAT reports, and the company will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less. Coherus’ version of Humira, one of the world’s best-selling medicines, will carry a $995 list price for a carton of two autoinjectors, which is an 85% discount from the $6,922 that AbbVie charges for the branded product. Coherus will also sell its drug at a discount to the Mark Cuban Cost Plus Drug company, which will market the treatment for about $579.

The U.S. Food and Drug Administration approved a second vaccine to protect older adults against RSV, STAT tells us, licensing Pfizer’s Abrysvo for adults 60 and older. The decision comes about a month after the agency approved GSK’s Arexvy, the first-ever vaccine against respiratory syncytial virus, or RSV. Neither vaccine is currently available for use. The Centers for Disease Control and Prevention must recommend the vaccines before they can be sold, a process expected to conclude later this month.

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In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.

Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthritis and other conditions. At the same time, Coherus will sell its drug at a discount to the Mark Cuban Cost Plus Drug Company, which will market the treatment for about $579.

The lowball pricing for the drug, which will become available in July, has the potential to alter one of the most closely watched product rollouts by pharmaceutical companies in many years. After enjoying a monopoly that yielded billions of dollars in annual sales, AbbVie is expected to face at least eight biosimilar rivals to Humira by the end of the year.

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FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.

The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.

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The rotation will likely include this, this, this and this. And what about you? Once again, this is a wonderful time to enjoy the great outdoors — beaches, woods, and lakes are beckoning. Or you could putter about your castle — a little spring cleaning is a good thing. And if mom is around, remember to say hi. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The U.S. Senate health committee passed a package of bills aimed at speeding generic drug competition and reining in pharmacy benefit managers, but it failed to pass an ambitious reform despite strong bipartisan support, STAT explains. The committee passed, 18 to 3, a bill that would ban pharmacy benefit managers from using spread pricing. The bill would also require that pharmacy benefit managers disclose rebates, fees, and other payments they receive and pass them on to the insurers for whom they negotiate the concessions. Lawmakers did not vote on a bill that would ban pharmacy benefit managers from charging administrative fees based on a percentage of a drug’s list price.

Pfizer chief executive officer Albert Bourla indicated that pharmaceutical companies will likely take legal action against Medicare drug price negotiations, CNBC tells us. Bourla referred to a provision in the Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. Bourla called the plan “negotiation with a gun to your head.” The first negotiations start in September and new prices will go into effect in 2026. He said the most “certain way” to stop negotiations would be to call on Congress to introduce legislation that will revise the plan, but noted he is “not optimistic” about that happening.

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At issue is a maneuver called alternative funding, which a growing number of drugmakers contend exploits their charitable programs. Basically, a plan sponsor excludes certain expensive drugs from coverage and taps an outside vendor to help patients obtain the medicines for free from patient assistance programs run by drug makers or foundations.

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taxes, according to a memo by a U.S. Senate Committee.

Specifically, the average effective tax rate for seven of the biggest drugmakers fell by 40% — dropping to 11.6% in 2020, down from 19.6% in 2016. In 2017, a new law was passed that permanently lowered corporate tax rates from 35% to 21%. Meanwhile, many of the largest pharmaceutical companies reported that 75% of their profits came from overseas.

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