A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.
Biosimilar-to-biosimilar switching – moving patients between two different biosimilar versions of the same brand biologic – is “a safe and effective clinical practice,” a new paper published in BioDrugs has concluded, based on a review of biosimilar-to-biosimilar switching studies.
However, the paper points out that the practice “is not covered by current health authority regulations or guidance” anywhere in...
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The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
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.
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.
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 continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
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.
