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Further Victory For Celltrion and Teva, As Their Trastuzumab Biosimilar, Herzuma, Receives FDA Approval

 
• By Dean Rudge

Less than a month after the FDA greenlit their Truxima (rituximab-abbs) biosimilar, partners Celltrion and Teva are toasting approval for their Herzuma (trastuzumab-pkrb) biosimilar, albeit with a limited set of indications; a date for market entry is also unclear at this stage.

Archery
Bullseye for Celltrion and Teva, as they bag trastuzumab and rituximab approvals in quick succession. • Source: Shutterstock

Celltrion is celebrating its second oncology biosimilar approval in the US in the past month with a US Food and Drug Administration (FDA) nod for its trastuzumab biosimilar, Herzuma (trastuzumab-pkrb) for intravenous injection, for which Teva will enjoy exclusive commercialisation rights upon market entry.

Formulated as 420mg lyophilized powder for injection in a multiple-dose vial for reconstitution, Herzuma has been approved with two breast cancer indications matching Genentech’s Herceptin reference brand: for HER2-positive

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