In the European Union (EU), a legal framework for approving biosimilars was established back in 2003. This framework allows for biosimilars to be approved using an abbreviated pathway centrally via the European Medicines Agency (EMA) .
EMA first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006, and since then the agency has developed many general and specific guidelines for biosimilars .
In light of continuing increases in healthcare costs, particularly for cancer drugs, payers, providers and patients are increasingly turning to biosimilars as a strategy for containing the cost of cancer care, according to Dr Gary Lyman of the Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA [3, 4]. Although the savings are not expected to be on the same scale as generics, even savings of 20% to 30% compared to the reference product, as have been observed in Europe and other markets , could make biosimilars a lucrative alternative.
In Europe, 38 biosimilars have been approved to date and these include 13 biosimilars to treat or support patients with cancer . However, despite the fact that biosimilars have been approved and used safely in the EU since 2006, uptake in Europe still varies widely between different Member States . This only highlights the need for continuing education for payers, prescribers and patients when it comes to biosimilars.
Therefore, just like in the US, it is also important in Europe to get professional bodies on board when it comes to biosimilars. In January 2017, the European Society of Medical Oncology (ESMO) published a position paper about biosimilars .
Regarding extrapolation of indications ESMO states that ‘extrapolation to all clinical indications may be acceptable in the EU, and globally, if there are enough relevant data related to the safety and efficacy of the biosimilar, any differences in the data are appropriately justified’. With respect to interchangeability and switching, ESMO says this should only be permitted if: (1) the physician is well-informed about the products; (2) the patient is fully briefed by the physician; and (3) a nurse is closely monitoring the changes and tracking any adverse events.
Dr Lyman concludes that ‘although biosimilars will have an important role in the future care of patients with cancer and in the stimulation of scientific innovation, the appropriate biologic[al] product prescribed ultimately must be determined after full discussion between the patient and treating oncologist’.
Conflict of interest
The author of the research papers [3, 4] reported conflicts of interest, including being an advisor/consultant for Halozyme, G1 Therapeutics and Coherus Biosciences and having received research funding from Amgen. For full details of the author’s conflict of interest, see the research papers [3, 4].
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:
Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care
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.
Biosimilars in oncology in the US
Opportunities and challenges for biosimilars in oncology
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2. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 1]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
3. Lyman GH. Emerging opportunities and challenges of biosimilars in oncology practice. J Oncol Pract. 2017;13(9_suppl):7s-9s.
4. Lyman GH. Biosimilars in the changing cancer care landscape. ASCO Daily News. 3 June 2017.
5. GaBI Online - Generics and Biosimilars Initiative. The economic impact of biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 1]. Available from: www.gabionline.net/Biosimilars/Research/The-economic-impact-of-biosimilars-in-the-US
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars penetration in Europe varies widely [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 1]. Available from: www.gabionline.net/Reports/Biosimilars-penetration-in-Europe-varies-widely
7. GaBI Online - Generics and Biosimilars Initiative. European oncologists back biosimilars with position paper [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 1]. Available from: www.gabionline.net/Biosimilars/General/European-oncologists-back-biosimilars-with-position-paper
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