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STAT+: Net prices for medicines fell considerably in 2023’s last quarter, mostly thanks to Humira biosimilars

STAT

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.

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Biosimilars will gain ground in 2023 with Humira launches — and that’s just the beginning

PharmaVoice

In Amgen's 2022 Biosimilars Trend Report, the company tracks the progress and potential of the copycat drugs as they reach a pivotal moment.

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The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars

Drug Channels

As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace. For 2025, the Big Three PBMs shifted national formularies to favor their private-label biosimilars over Humira and its many biosimilar competitors. What do you think?

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2022 WHO Biosimilar Guideline improves access, IGBA says

European Pharmaceutical Review

The International Generic and Biosimilar Medicines Association (IGBA)’s new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline suggests how the guideline provides great opportunity to revaluate how regulatory requirements can better advance biosimilar access.

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Opinion: What does ‘bona fide competition’ actually mean in the biologics market?

STAT

The Inflation Reduction Act (IRA), passed in August 2022, gives Medicare pricing power over therapies that both cost Medicare lots of money and have by 2026 enjoyed market exclusivity for a certain number of years — nine for small-molecule drugs and 13 for biologics.

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GaBI Publishes Report on ASBM Webinar on Biosimilar Success Factors

Safe Biologics

The Generics and Biosimilars Initiative (GaBI) has published a report on the first of two webinars the organization recently co-hosted with ASBM. The next topic will be “Ophthalmic Biosimilars” in November 2022. Watch video of the Non-Medical Switching webinar here. These webinars are the first two in a series.

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FDA Accepts BLA for Shanghai Henlius Biotech’s and Organon’s HLX14, a Denosumab Biosimilar

Big Molecule Watch

On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). In 2022, Shanghai Henlius Biotech granted Organon exclusive commercialization rights for HLX14 in the U.S., EU, and Canada.