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US Comparator Requirement For Interchangeable Biosimilars Would Hurt Industry

 
• By Sue Sutter

US FDA’s recommendation against use of foreign-licensed reference products in clinical switching studies would result in procurement challenges and higher costs for biosimilar developers while also limiting where such studies could be conducted, some companies say.

The US FDA’s stance against use of foreign-licensed reference biologics in interchangeability switching studies carries practical and economic challenges that will negatively impact the ability to conduct such trials, biosimilar manufacturers say.

In comments on FDA’s draft guidance on interchangeability, some biosimilar manufacturers, including Sandoz Inc. and Pfizer Inc

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EU Biosimilar Filings, Opinions And Approvals

 
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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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
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Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
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More from Biosimilars & Generics

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
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