for its therapeutic drug monitoring tests for Humira and Remicade, as well as their biosimilars, in patients with inflammatory bowel disease, according to a company release.These are the first therapeutic drug monitoring tests authorized by the FDA for Humira (adalimumab, AbbVie) and Remicade (infliximab, Janssen) biologic therapies, in addition to the biosimilars Amjevita (adalimumab-atto, Amgen), Inflectra (infliximab-dyyb; Celltrion/Pfizer) and Renflexis (infliximab-abda, Samsung and Merck).“Therapeutic drug monitoring of

PAHO seeks to strengthen pharmaceutical services in the Americas

Cristina Mitchell

4 Oct 2023

The company in July launched a branded biosimilar, Cyltezo, priced at a 5% discount to Humira's current list price of $6,922 per month. Boehringer's close-copies of Humira are the only ones that can be substituted for the original without consulting the prescriber after being designated as interchangeable by the U.S. Food and Drug Administration.

Eight Humira biosimilars from companies including Novartis unit Sandoz and Amgen were launched in the U.S. this year. Several of those companies are also seeking interchangeability status with the FDA to better compete with Humira and Cyltezo.

Until recently, Humira was the world's biggest-selling prescription drug. It had sales of $21.2 billion in 2022.

Unlike easy to manufacture pills that can be copied and sold as generics at a huge discount once patents lapse, complex biologic medicines made from living cells cannot be exactly duplicated. Their close alternatives are called biosimilars.

Boehringer executive Stephen Pagnotta said the company wanted to make a lower-cost version of Cyltezo available to pharmacy benefit managers (PBMs) looking to add cheaper Humira biosimilars on their formulary, and for healthcare systems that act as both insurer and provider and typically do not seek after-market discounts.

"We felt the dual pricing approach could really help with payers and PBMs to ensure that biosimilars are available to as many patients as possible," he said.

Pagnotta said Boehringer was in negotiations with PBMs to put the unbranded version on their lists of covered medicines over the coming months.

UnitedHealth Group's Optum RX, one of the largest U.S. PBMs, said it has already committed to covering the lower-cost version of Cyltezo on its formulary.

Sandoz and Amgen also launched Humira biosimilars with two pricing tiers. Sandoz's Hyrimoz is sold at a 5% discount to Humira's price, while its unbranded version carries an 81% discount.

Healthcare experts have said the heavily discounted versions of Humira may not be made widely available because they are unlikely to appeal to PBMs like CVS Health's Caremark, Cigna Group's Express Scripts, and Optum RX, which together control 80% of the prescription drug market.

PBMs have come under increasing scrutiny for taking some of their fees as a percentage of the discounts they negotiate for drugs they cover, which some lawmakers have said can be an incentive for favoring higher-priced medicines in their negotiations.

Read also: Eli Lilly-Boehringer Ingelheim Jardiance gets USFDA approval for adults with chronic kidney disease

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View the full post Changing the tune of Gender-Based Violence on NOW Grenada.

Nonetheless, we are giving it a go. Hopefully, you will be a beneficiary, since we have assembled a few items of interest to help you start your own day. On that note, we hope that all goes well and that you conquer the world. And of course, do keep in touch. …

All the drugmakers that make the 10 prescription medicines subject to the first-ever price negotiations for the U.S. Medicare health program said they signed on to participate in the talks by the Oct. 1 deadline, Reuters notes. The penalties for not doing so would have been steep: Drugmakers would have to pay 65% to 95% taxes on their drug’s Medicare sales or withdraw all of their products from the Medicare and Medicaid programs, which together provide health benefits to 158 million Americans. At least seven of the drugmakers have sued the U.S. Department of Health and Human Services, which oversees the Medicare agency, calling the process unconstitutional price-setting.

AstraZeneca agreed to pay $425 million to settle U.S. product liability lawsuits related to the heartburn and stomach acid treatments Nexium and Prilosec, which some users said caused kidney damage, Bloomberg News says. The settlement resolves litigation in New Jersey and Delaware courts. A single case is still pending in Louisiana, with a trial set for next year. AstraZeneca said it continues to believe the claims are without merit and admits no wrongdoing, but settled to avoid costly legal procedures. Heartburn medications have been the subject of a range of concerns in recent years. In June, GSK settled litigation with a man who claimed its Zantac treatment caused his cancer.

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PAHO advances technical cooperation with Argentina to strengthen regional production of mRNA vaccines

Cristina Mitchell

2 Oct 2023