Further Victory For Celltrion and Teva, As Their Trastuzumab Biosimilar, Herzuma, Receives FDA Approval
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.
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Celltrion and Teva have now received a Health Canada approval for their Herzuma trastuzumab biosimilar. However, notices of compliance have already been granted for rival biosimilars from Mylan and Pfizer.
Lonza will help Celltrion to satisfy increasing global demand for biosimilar infliximab after signing a deal to manufacture the drug substance for Remsima.
Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.