Drug Review Profile: Inflectra sponsor submitted nonproprietary name suffixes that were both devoid of meaning and meaningful; agency concluded nonmeaningful suffix "-dyyb" was unlikely to be source of error.
With its naming policy in flux, FDA allowed Celltrion Inc. to hedge its bets and propose suffixes that were both meaningful and devoid of meaning for the nonproprietary name of Inflectra (infliximab-dyyb), its biosimilar to Janssen Biotech Inc.'s Remicade (infliximab).
The timing of an FDA draft guidance created some uncertainty for Celltrion as to how it should approach a nonproprietary...
<p>Executive Summary</p> <p>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.</p>
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
<p>Executive Summary</p> <p>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.</p>
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<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
<p>Executive Summary</p> <p>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.</p>
