The originator product, Roche’s Herceptin (trastuzumab), was approved by the US Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000 [1]. Since its approval, use of Herceptin has altered the natural history of HER2-positive breast cancer, according to Chau T Dang, ‘with patients now living longer with a disease that was once much more difficult to treat’ [2]. Use of the drug has ‘also led to a significant improvement in disease-free and overall survival in patients with early-stage disease and was approved in this setting in 2006’. According to the World Health Organization’s List of Essential Medicines, trastuzumab is one of the most effective and safe treatments needed in a health system.

In 2016, Herceptin had worldwide sales of CHF 6.8 billion (US$6.7 billion). The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [1], opening up the door to biosimilars.

Results from the phase III HERiTAge study for Mylan/Biocon’s biosimilar trastuzumab candidate, MYL-1401O, according to Mylan, confirmed the efficacy, safety and immunogenicity of MYL-1401O compared to Roche’s Herceptin (trastuzumab) both given in combination with paclitaxel as first-line therapy every three weeks in patients with HER2+ metastatic breast cancer [3]. MYL-1401O was equivalent to trastuzumab in terms of overall response rates at 24 weeks in patients with previously untreated metastatic HER2+ breast cancer. At 48 weeks, there were no differences in time to progression or progression-free or overall survival. Additionally, there were no differences in adverse events.

Ms Dang concludes that ‘the importance of these findings cannot be underscored sufficiently. The development of a biosimilar for treatment in this setting could mean not only lower healthcare costs for society overall, but also greater access to an important life-saving or life-extending drug for a larger breast cancer population across the globe’.

MYL-1401O was submitted to the European Medicines Agency (EMA) for approval in August 2016 [4] and to the US Food and Drug Administration (FDA) in November 2016 [5].

Conflict of interest
The author of the research paper [1] declared that there was no conflict of interest.

Editor’s comment
Readers interested to learn more about biosimilars in oncology are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Biosimilars in oncology: current and future perspectives

GaBI Journal is indexed in Embase, Scopus, Thomson Reuters’ ESCI, and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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References
1. 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
2. Chau T Dang. Trastuzumab biosimilar could lead to lower health-care costs and greater drug access for patients with metastatic breast cancer. The ASCO Post. 2017 April 25.
3. GaBI Online - Generics and Biosimilars Initiative. Mylan presents comparability data for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Biosimilars/Research/Mylan-presents-comparability-data-for-trastuzumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-EMA
5. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-FDA

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