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Biosimilars: Next User Fee Cycle Will Be Judged On US FDA's Approvals, Rep. Burgess Says

 
• By Derrick Gingery

Chair of the House Energy and Commerce Health Subcommittee expects BsUFA II also to be judged on FDA's review process predictability.

Human antibody

The US FDA should expect enhanced congressional pressure to get more biosimilars on the market in the coming years. Rep. Michael Burgess, R-Texas, who chairs the House Energy and Commerce Health Subcommittee seems troubled by the fact that there have been only four approvals during the first five years of the biosimilar user fee program.

Burgess said March 15 during a biosimilars policy briefing sponsored by The Atlantic that FDA will be judged during the...

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MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By Dean Rudge

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Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 
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