Zarxio Coverage On Par With Innovators Even Without Interchangeable Designation

Avalere survey suggests payers are comfortable with covering the biosimilar but not necessarily actively promoting it over Neupogen or other competing brands.

Identical twins
Which one is the biosimilar?

Nearly all US employer-sponsored health plans responding to a large survey reported they are covering Sandoz Inc.'s biosimilar Zarxio (filgrastim-sndz) and coverage is comparable to that of its reference drug, Amgen Inc's Neupogen, and other competitors.

Ninety-four percent of plans are covering the biosimilar, according to the survey, which was conducted by Avalere Health. The results...

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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.