Biosimilars' Pediatric Pressures Could Push Them Toward Interchangeability

Study and formulation requirements under PREA mean that interchangeability application might not be much more of a leap.

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Pediatric development laws could wind up directing biosimilar sponsors toward interchangeability whether they want it or not.

For Sandoz Inc. and its GP2015, a proposed biosimilar to Amgen Inc.'s tumor necrosis factor blocker Enbrel (etanercept),...

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GB-Free-Tracker-The Secret to Walking More: It’s Not Counting Steps

We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.

Regeneron’s Linvoseltamab CRL Underlines Risks Of Third-Party Manufacturers

 

The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.

Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

 

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

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.

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Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

 

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

Novartis Takes Fight To The FDA After US Entresto Generic Approval

 
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Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

EU Biosimilar Filings, Opinions And Approvals

 
• By 

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.