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Biosimilars and sustainability Posted 23/06/2017

Competition between brand-name biologicals and biosimilars has the potential to reduce future cancer costs, according to researchers from Italy [1].

In order to facilitate the approval of biosimilars, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have introduced guidelines outlining an abbreviated pathway [2, 3].

However, to really benefit from biosimilars and increase their use, confidence in the development of biosimilars needs to be increased. This then calls for a clear position from scientific associations, such as the European Society for Medical Oncology (ESMO).

In January 2017, ESMO published a position paper on biosimilars saying that ‘biosimilars create opportunities for sustainable cancer care’. The article outlined the approval standards for biosimilars, how to safely introduce them into the clinic and the potential benefits for patients and healthcare systems. It covers aspects related to definition, forms of biosimilars, labelling, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, responsibilities among prescribers and pharmacists, potential impact on financial burden in health care and the current scenario and future prospects of biosimilars in Europe and the rest of the world [4].

Key points to be addressed when it comes to biosimilars are extrapolation, interchangeability, switching and automatic substitution. ESMO recommends that extrapolation of indications should be allowed only if a solid scientific background is provided and that automatic substitution be avoided.

With respect to testing the biosimilar in a sensitive and homogeneous population, authors Bria and Conte point to the recently published example of trastuzumab biosimilars. In this trial patients with HER2+ metastatic breast cancer were tested for overall response rate (ORR) at 24 weeks.

EMA requires that the most sensitive endpoint and population be used where any difference between the biosimilar and originator is most easily detected. However, data indicate that ORR does not always correlate with survival with the strength of a surrogate endpoint. In fact, according to Jackisch et al., if the same equivalence margins are used for ORR (metastatic disease) and pCR (for early/locally advanced disease), the predicted maximum loss in long-term efficacy with the biosimilar trastuzumab versus originator trastuzumab is smaller for pCR (pathologic complete response) than for ORR.

Finally, Bria and Conte call for ‘the development of a serious post-marketing surveillance plan’. This, they say will ‘increase the amount of evidence and information regarding biosimilars’ thereby ‘increasing confidence in treating physicians and pharmacists’.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts 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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1. Bria E, Conte P. Biosimilars as a strategy to improve sustainability. ESMO Open. doi:10.1136/esmoopen-2017-000192. Published 29 May 2017.
2. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. European oncologists back biosimilars with position paper [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Biosimilars/General/European-oncologists-back-biosimilars-with-position-paper

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