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BioDrugs

, Volume 32, Issue 5, pp 515–518 | Cite as

PF-05280014: A Trastuzumab Biosimilar

  • Julia Paik
Adis Biosimilar Brief

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.

Notes

Compliance with Ethical Standards

Disclosure

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.

References

  1. 1.
    European Medicines Agency. Trazimera: summary of product characteristics. 2018. http://ec.europa.eu/. Accessed 4 Sept 2018.
  2. 2.
    Lammers PE, Dank M, Masetti R, et al. Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer. Br J Cancer. 2018;119:266–73.CrossRefGoogle Scholar
  3. 3.
    Tokunaga E, Rai Y, Yoshimatsu H, et al. PF-05280014 (a potential trastuzumab biosimilar) for HER2+ metastatic breast cancer: Japanese subgroup analysis [poster no. P3-015]. In: Japanese Society of Medical Oncology annual meeting. 2018.Google Scholar
  4. 4.
    Yin D, Barker KB, Li R, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol. 2014;78(6):1281–90.CrossRefGoogle Scholar
  5. 5.
    Pegram M, Tan-Chiu E, Freyman A, et al. A randomized, double-blind study of PF-05280014 (a potential trastuzumab biosimilar) vs trastuzumab, both in combination with paclitaxel, as first-line treatment for HER2-positive metastatic breast cancer [abstract no. 238PD]. Ann Oncol. 2017;28(Supplement 5):74–5.Google Scholar
  6. 6.
    Cesarec A, Likic R. Budget impact analysis of biosimilar trastuzumab for the treatment of breast cancer in Croatia. Appl Health Econ Health Policy. 2017;15(2):277–86.CrossRefGoogle Scholar
  7. 7.
    Blackwell K, Gligorov J, Jacobs I, et al. The global need for a trastuzumab biosimilar for patients with HER2-positive breast cancer. Clin Breast Cancer. 2018;18(2):95–113.CrossRefGoogle Scholar
  8. 8.
    European Medicines Agency. CHMP assessment report: Trazimera. 2018. http://www.ema.europa.eu/. Accessed 4 Sept 2018.
  9. 9.
    Boyle P, DeGruttola H, Ferrari S, et al. Characterization and comparison of PF-05280014, proposed trastuzumab biosimilar to the licensed product [poster no. M1037]. In: American Association of Pharmaceutical Scientists (AAPS) national biotechnology conference. 2013.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

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