PF-05280014: A Trastuzumab Biosimilar
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.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Julia Paik is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
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