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Biosimilar Sponsors May Be Going Overboard On Clinical Data, FDA Says

 
• By Sue Sutter

Studying multiple indications 'not the right way to approach biosimilars,' agency says; Amgen conducted more studies than needed for its proposed Humira biosimilar to enhance patient and physician confidence.

Some biosimilar product sponsors are doing more clinical studies than FDA believes necessary to support licensure.

"We are seeing biosimilar sponsors proposing to do multiple studies in multiple indications, which to us is not the right way to approach biosimilars," FDA Division of Pulmonary, Allergy and

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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More from Regulatory Trackers

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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