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BioDrugs. 2018 Oct;32(5):515-518. doi: 10.1007/s40259-018-0308-z.
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.
PF-05280014（Trazimera™）是欧盟批准的第四种曲妥珠单抗生物类似药。它被批准用于曲妥珠单抗已批准的所有适应证，包括 HER2 阳性转移性或早期乳腺癌和转移性胃癌。PF-05280014与曲妥珠单抗的理化特性和药效动力学特性相似，在转移性或早期 HER2 阳性乳腺癌女性以及健康男性志愿者中已显示出药物代谢动力学的相似性。PF-05280014在 HER2 阳性转移性乳腺癌女性中的疗效与曲妥珠单抗相当，在 HER2 阳性早期乳腺癌女性中的疗效与曲妥珠单抗相当。PF-05280014的免疫原性、耐受性和安全性与曲妥珠单抗相似。曲妥珠单抗在治疗 HER2 阳性乳腺癌和胃癌中的作用已得到充分证实，PF-05280014为需要曲妥珠单抗治疗的患者提供了有效的生物类似药替代方案。
