The ruling from the London High Court on 10 April 2014 stated that the two patents (relating to dosage and composition) were invalid, ruling in favour of US-based generics firm Hospira, who brought the case against Roche’s Genentech unit.

Herceptin, an injectable monoclonal antibody biological drug, had worldwide sales of CHF 6.1 billion (US$6.8 billion) for 2013.

Hospira, along with its partner Celltrion, gained European approval for the first monoclonal antibody biosimilar Inflectra/Remsima (infliximab), in September 2013 [1]. The drug is a biosimilar of Johnson & Johnson’s blockbuster arthritis treatment Remicade (infliximab).

The primary patent on Herceptin expires on 28 July 2014 in Europe and in the US in 2019. However, it is unlikely that anyone will be ready with a trastuzumab biosimilar by July 2014 as the European Medicines Agency is not currently reviewing any biosimilars applications for the drug [2], but we may not have to wait too long. According to the European Union’s Clinical Trials Register, South Korean biotechnology company Celltrion is starting a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer [3]. Celltrion has already gained approval for its traztuzumab biosimilar (Herzuma) in South Korea [4]. In February 2014, generics companies Biocon and Mylan also launched a ‘similar biologic’ in India [5]. While other manufacturers also developing trastuzumab biosimilars include biotech giant Amgen, Novartis and Pfizer.

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related articles

Robust data for biosimilar trastuzumab programmes presented

Biocon and Mylan challenge Indian ban on trastuzumab ‘similar biologics’

References

1.   GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 25]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar

2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – 2013 Q4 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2013-Q4

3.   GaBI Online - Generics and Biosimilars Initiative. Celltrion starts phase III biosimilar trastuzumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 25]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-starts-phase-III-biosimilar-trastuzumab-trial

4.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 25]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea

5.   GaBI Online - Generics and Biosimilars Initiative. Mylan launches trastuzumab ‘similar biologic’ in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 25]. Available from: www.gabionline.net/Biosimilars/News/Mylan-launches-trastuzumab-similar-biologic-in-India

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