NHS England Proposes Boosting Biosimilar Use

Latest Draft NHS Standard Contract Includes Prescribing Requirement

In its latest draft standard contract for 2025/26, the National Health Service in England has proposed enhanced prescribing requirements “in recognition of the increasing importance of biosimilars in the provision of biological medicines.”

NHS England has proposed enhanced provisions to promote biosimilars

An enhanced requirement for the National Health Service in England to use “best-value biological medicines” whenever possible has been included in a new draft NHS standard contract published by the NHS for 2025/2026.

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Stelara Biosimilars Storm US Market With 85% Discounts Ahead Of Price Drop In Medicare

 
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The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.

Belgian Body Hits Out At Roche For Delaying Biosimilar Competition

 
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Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

US FDA May Be Shifting Its Thinking On Biosimilar Trials

 
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Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.

Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

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EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

Recent And Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.