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Biosimilars: Is Small Dip In Development Indicative Of Sustained Downward Trend?

 
• By Michael Cipriano

As US FDA sees dip in application development, experts offer contrasting assessments about future of biosimilars at AAM's GRx Biosims conference. 

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The US FDA saw the number of biosimilar development programs in the agency's Biosimilar Biological Product Development (BPD) program take a dip in the later months of 2017. But are these few months of data indicative of a new downward trend of investment in alternatives to originator products?

It is likely too soon to draw any definitive conclusions. But experts nevertheless offered contrasting opinions about whether biosimilars will...

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EU Biosimilar Filings, Opinions And Approvals

 
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More from Biosimilars & Generics

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
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EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
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