Manchin Pushback Bad News For Biden But Good News For Biosimilars

Build Back Better Runs Into Roadblock As Democratic Senator Declines Support

 
• By Chloe Kent
  
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Joe Manchin’s refusal to vote in favor of the Biden administration’s Build Back Better legislation could prove to be a boon for the US biosimilars industry, following weeks of condemnation from the Association for Accessible Medicines.

US President Joe Biden hosts West Virginia Senator Joe Manchin in the White House Oval Office to discuss his vote on Biden's Build Back Better Infrastructure initiative
Negotiations between Biden and Manchin have reportedly broken down • Source: Alamy

The Build Back Better Act’s number could be up before it has even begun, after Democratic senator Joe Manchin announced shortly before Christmas that he would not vote for the legislation due to concerns surrounding its cost and approach to spending on healthcare, childcare and climate programs. The $1.75tn spending package includes historic federal investment in social resources, to be funded by tax increases on the wealthiest US citizens and businesses.

Manchin has already pressured the party to cut planned Build Back Better spending from $3.5tn to $1.75tn. His support is...

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An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

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