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FDA Approves Novel BioBetter for UC & Crohn’s – Zymfentra

Earlier this week we sent a Report outlining why the term ‘BioBETTER’ should be added to your pharma vocabulary. Today we introduce a new biosimilar that is considered a BioBETTER. If you missed that report a BioBETTER is a product that is a biosimilar that has been altered in a way to improve effectiveness, ease of use, etc. A poor example might be the addition of an additive like STP to your gas tank to improve engine performance.

The FDA recently approved a new biosimilar, Zymfentra (infliximab-dyyb) from Celltrion, Inc.  Zymfentra is a subcutaneous (SC) formulation of Inflectra, a biosimilar to Remicade.  It is the world’s first and only subcutaneous infliximab product. 

Zymfentra is a novel tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously and moderately to severely active Crohn’s disease following treatment with an infliximab product administered intravenously. The approval, however, included a Black Box Warning citing a long list of warnings and precautions. 

The label specifies that Zymfentra is for subcutaneous use only. Additionally, Zymfentra is indicated as maintenance treatment only, starting at Week 10 and thereafter for patients who must complete an intravenous induction regimen with an infliximab product before starting Zymfentra.

CLICK HERE to access Prescribing Information

We will strive to identify any new biosimilar approval that qualifies for the unique designation as a BioBETTER.

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