Pfizer submitted its biosimilar application to FDA for its trastuzumab biosimilar candidate, Trazimera (PF 05280014), back in September 2017 [1]. The agency, however, initially rejected the application in April 2018, requesting ‘additional technical information’ [2].

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast and gastric cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast and gastric cancers.

Trazimera (trastuzumab-qyyp) has been approved for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fifth biosimilar from Pfizer to be approved for marketing in the US.

The FDA approval was based on review of a comprehensive data package, which, according to Pfizer, ‘demonstrated a high degree of similarity between Trazimera and the originator product’. The data package included results from Pfizer’s phase III REFLECTIONS B327-02 study, which showed that the biosimilar is non-inferior to Herceptin [3]. This study, according to Pfizer, ‘showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between Trazimera and the originator product in patients with first line HER2 overexpressing metastatic breast cancer’.

Pfizer also received approval for Trazimera in the European Union in July 2018 [4] and in Japan in September 2018 [5].

Trazimera has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Pfizer’s trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 22]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Pfizer-s-trastuzumab-biosimilar 
2. GaBI Online - Generics and Biosimilars Initiative. FDA rejects trastuzumab and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-trastuzumab-and-rituximab-biosimilars 
3. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar PF 05280014 non-inferior to Herceptin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 22]. Available from: www.gabionline.net/Biosimilars/Research/Trastuzumab-biosimilar-PF-05280014-non-inferior-to-Herceptin 
4. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars gain EC approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 22]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-gain-EC-approval 
5. GaBI Online - Generics and Biosimilars Initiative. Originator biologicals and biosimilars under attack in UK and Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 22]. Available from: www.gabionline.net/Biosimilars/General/Originator-biologicals-and-biosimilars-under-attack-in-UK-and-Japan

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