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 cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is used to treat certain breast cancers.

Pfizer submitted the application for approval of its trastuzumab biosimilar (PF‑05280014) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in September 2017 [1].

In its complaint in the US District Court of Delaware, Roche’s Genentech claims that Pfizer’s FDA application for its proposed trastuzumab biosimilar infringes on 40 of Roche’s patents. Roche is claiming compensation for lost sales if Pfizer continues with the launch of its product before patents related to Herceptin expire in June 2019 [1].

Roche is right to be worried, Herceptin (trastuzumab), which was approved by FDA in September 1998 and by EMA in August 2000 [2], had 2016 worldwide sales of CHF 6.8 billion (US$6.7 billion), with US$2.5 billion coming from the US alone (5% of Roche’s annual revenue). And the odds seem to be stacked against Roche. In September 2017, a UK court ruled in favour of Pfizer’s subsidiary, Hospira, and denied Roche/Genentech’s efforts to extend its protection for Herceptin through additional patents to prevent the launch of Hospira’s biosimilar candidate in that country.

Pfizer is not the only company with Herceptin in its sights. Mylan submitted its application for its proposed trastuzumab biosimilar (MYL‑1401O) to FDA for approval in November 2016 [3], although the FDA’s target action date was extended until 3 December 2017 [4]. Mylan entered a deal with Roche earlier in 2017 that will provide it licenses to market its biosimilar in countries around the world after an undisclosed date. In addition, rival biosimilars makers Amgen (ABP 980) and Celltrion (CT‑P6) also submitted applications for their trastuzumab biosimilars to FDA in July 2017 [5].

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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 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Pfizer-s-trastuzumab-biosimilar
2. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-FDA
4. GaBI Online - Generics and Biosimilars Initiative. Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/General/Biocon-withdraws-EU-applications-for-trastuzumab-and-pegfilgrastim-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Two trastuzumab biosimilars submitted to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/News/Two-trastuzumab-biosimilars-submitted-to-FDA

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