Six months out from the World Health Organization ending the global health emergency brought on by the pandemic, there’s no need for the World Trade Organization to expand a five-year intellectual property (IP) waiver for vaccines to COVID-19-related drugs, devices and diagnostics.
Of all that happened in 2023, Medicare price negotiations probably top the list as the biggest U.S. biopharma disruptor. Although Congress cleared the way for the negotiations last year when it passed the partisan Inflation Reduction Act, they weren’t fleshed out until this year when the Centers for Medicare & Medicaid Services issued guidance detailing the rules of the negotiating road. And as usual, the devil is in the details.
In keeping with a provision in the Inflation Reduction Act, the U.S. Department of Health and Human Services will not implement a final rule removing the anti-kickback safe harbor for the rebates drug companies pay pharmacy benefit managers until Jan. 1, 2032.
In his latest effort to boost the U.S. manufacturing base, President Joe Biden is invoking the Defense Production Act (DPA) to expand the domestic production capabilities for essential medicines, medical countermeasures (MCMs) and their critical inputs.
Nearing the end of 2023, South Korea’s National Assembly approved hiked-up budgets for three of its major health care agencies. Its health policy think tank also forecast an uptick in industry exports in 2024.
The U.S. FDA issued a complete response letter for Zealand Pharma A/S’s NDA seeking approval of dasiglucagon for the prevention of treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism, citing deficiencies identified during an inspection at a third-party contract manufacturing facility.
Drug guidances are still pouring forth from the U.S. FDA as 2023 winds to an end. The latest batch deals with issues as varied as the reformulation of drug products that use carbomers manufactured with benzene, potency assurance for cellular and gene therapies, the quality of topical eye treatments, and the development of drugs and biologics for rare diseases.
As their term in office winds to a close, MEPs in the two main political groupings of the European Parliament still have huge differences of opinion over the proposed reform of the EU pharmaceutical regulation and how best to achieve the stated aims of improving patient access whilst encouraging innovation.
Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July.
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