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Best Of Biosimilar Agreement: FDA, Industry Tout Written Response, Pre-Submission Meeting

 
• By Brenda Sandburg

FDA's Leah Christl and Amgen and Sandoz representatives discuss key achievements of BsUFA II at DIA meeting; Christl expects to see interchangeable biosimilars come to market within the next two years.

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How can biosimilar sponsors make the best use of the second Biosimilar User Fee Agreement (BsUFA II)?

FDA's Leah Christl, associate director for therapeutic biologics in the Center for Drug Evaluation and Research, was asked this question during a panel discussion at the Drug Information Association's annual meeting in Chicago June 20

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
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Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
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The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

More from Biosimilars & Generics

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
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An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.