FDA approves trastuzumab biosimilar Herzuma Posted 01/02/2019

On 14 December 2018, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Herzuma (trastuzumab-pkrb), for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.

The product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had sales of CHF 7.0 billion (US$7.5 billion) in 2017 [1]. The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [2].

Herzuma is produced by South Korean biotechnology company Celltrion and Israel-based Teva Pharmaceutical Industries (Teva). The companies first submitted their application for approval to FDA in July 2017 [3]. However, this was rejected by the agency in April 2018 [4]. The companies then resubmitted their application to FDA in May 2018 [5].

Trastuzumab is a monoclonal antibody that interferes with the 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.

Herzuma has been approved for the following indications:

  • Adjuvant Breast Cancer of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer
    • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
    • as part of a treatment regimen with docetaxel and carboplatin
  • Metastatic Breast Cancer
    • in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
    • as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
  • In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

FDA’s approval of Herzuma was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic, clinical immunogenicity and other clinical data demonstrating that Herzuma is biosimilar to US Herceptin.

Herzuma 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.

The approval of Herzuma marks Celltrion/Teva’s second biosimilar to be approved by FDA. Truxima (rituximab-abbs) was approved in the US in November 2018 [6]. Celltrion also manufactures the infliximab biosimilar Inflectra (infliximab-dyyb) for Hospira (Pfizer), which was approved by FDA in April 2016 [7].

Celltrion/Teva also received European approval for their trastuzumab biosimilar, Herzuma, in February 2018 [8]. The companies have also received European approval for infliximab biosimilar Remsima in September 2013 and for rituximab biosimilars Truxima, Blitzima, Ritemvia and Rituzena (previously Tuxella) in February and July 2017 [9].

Celltrion and Teva entered into an exclusive partnership in October 2016 to commercialize Herzuma in the US and Canada.

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
2. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
3. GaBI Online - Generics and Biosimilars Initiative. Two trastuzumab biosimilars submitted to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Two-trastuzumab-biosimilars-submitted-to-FDA
4. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Celltrion-Teva-s-rituximab-and-trastuzumab-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Celltrion resubmits biosimilar trastuzumab to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-resubmits-biosimilar-trastuzumab-to-FDA
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-rituximab-biosimilar-Truxima
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
8. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Herzuma
9.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Celltrion, US FDA

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