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Curious Biosimilar Issues: More Workload, But Fewer US FDA Staff Needed

 
• By Derrick Gingery

The US FDA’s capacity planning formula indicates a smaller biosimilar program than a year ago, but says supplement, meeting and other work continue to increase.

Workload
Meetings and manufacturing supplements are estimated to rise in FY 2022, while one less biosimilar application is expected, compared to the current fiscal year. • Source: Alamy

Biosimilar program projections from the US Food and Drug Administration suggest fewer staff are needed than a year ago, even as several workload metrics continue to increase.

The agency’s capacity planning adjustment predictably estimated that funding for more full-time equivalent paid staff is necessary for the biosimilar...

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

EU Biosimilar Filings, Opinions And Approvals

 
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US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.

European Industry Calls For Support As It Juggles Multiple Challenges

 
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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.