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STAT+: As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’

STAT

One such case occurred last year, when a wave of Humira biosimilars entered the market and drug companies slashed the list prices of their insulin products. Continue to STAT+ to read the full story…

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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1,2 The reflection paper also highlights the limitations and diminishing value of CES in many biosimilar development programmes.

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

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January 2024 Newsletter

Safe Biologics

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

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April 2024 Newsletter

Safe Biologics

Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a r esponse published in GaBI Journal. Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such.

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EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development

Safe Biologics

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024. Read the concept paper here.

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ASBM Physician Survey on Interchangeable Biosimilars Finds Support for Maintaining Current Standards

Safe Biologics

Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars FOR IMMEDIATE RELEASE – September 4, 2024 Arlington, VA- U.S. physicians. physicians. In the U.S. In the U.S.