Abstract
PF-05280014 (Trazimera™) is the fourth biosimilar of the reference anti-HER2 antibody trastuzumab to be approved in the EU. It is approved for use in all indications for which reference trastuzumab is approved, including HER2-positive metastatic or early breast cancer and metastatic gastric cancer. PF-05280014 has similar physicochemical and pharmacodynamic properties to those of reference trastuzumab, and the pharmacokinetic similarity of the agents has been shown in women with metastatic or early HER2-positive breast cancer and healthy male volunteers. The efficacy of PF-05280014 was equivalent to that of reference trastuzumab in women with HER2-positive metastatic breast cancer and was comparable to that of reference trastuzumab in those with HER2-positive early breast cancer. The immunogenicity, tolerability and safety profiles of PF-05280014 were similar to those of reference trastuzumab. The role of reference trastuzumab in the management of HER2-positive breast and gastric cancers is well established and PF-05280014 provides an effective biosimilar alternative for patients requiring trastuzumab therapy.
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