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Biosimilars Could Give Brands the Boot Mid-Year Under Amendment Added to Senate PBM Reform Bill

 
• By Sarah Karlin-Smith

However, the low CBO score attached to the measure may suggest PBMs might not be incentivized to follow through on the congressional permission.

legs up in air with colorful cowboy coots in kicking motion
A measure to facilitate faster biosimilar coverage was added to the Senate Finance Committee PBM package • Source: Shutterstock

Medicare Part D plans could switch the coverage status of a reference biologic midyear if the plan adds a biosimilar for that product to the formulary, under an amendment added to the Senate Finance Committee’s pharmacy benefit manager reform package, which cleared the committee on a 26-1 vote 26 July.

The amendment from Sens. Debbie Stabenow, D-MI, and James Lankford, R-OK, was added to the chairman’s mark of the Modernizing and Ensuring PBM Accountability (MEPA) Act ahead of the markup.

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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

UK-India FTA Could Offer ‘Significant Benefits’ For Generics And Biosimilars

 
• By Dave Wallace

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Dr Reddy’s Gears For Tariffs Scenario To Ensure No US Supply Disruption

 
• By Anju Ghangurde

Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.

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ANI Raises Generics Guidance As Exclusive Prucalopride Drives Growth

 
• By Dean Rudge

ANI Pharmaceuticals says it has delivered an “exceptionally strong first quarter,” with total sales reaching over $197m, amid plans to kick off a Phase IV clinical trial for Cortrophin Gel for acute gouty arthritis later this year.

Aurobindo, MSN Fall To US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.

Aurobindo Racks Up Another Biosimilar Nod With Filgrastim In UK

 
• By Dave Wallace

Aurobindo’s run of biosimilar registration successes continues, with the firm’s CuraTeQ subsidiary picking up approval for its Zefylti version of filgrastim in the UK.