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Study Offers Support For Biosimilar-To-Biosimilar Switching

Practice Is Safe And Effective, But Not Covered By Current Regulations Or Guidance

 
• By Dave Wallace

A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.

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Biosimilar-to-biosimilar switching is examined in a new paper • Source: Shutterstock

Biosimilar-to-biosimilar switching – moving patients between two different biosimilar versions of the same brand biologic – is “a safe and effective clinical practice,” a new paper published in BioDrugs has concluded, based on a review of biosimilar-to-biosimilar switching studies.

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

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Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
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More from Biosimilars & Generics

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

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