The US Food and Drug Administration (FDA) made its landmark decision to approve Sandoz’s filgrastim biosimilar, Zarxio (filgrastim-sndz), for all five indications of the originator product (Neupogen) on 6 March 2015 [2]. To date, the agency has approved seven biosimilars [2] and in September 2017, it approved the first US biosimilar for the treatment of cancer, Mvasi (bevacizumab-awwb) [3].

The advent of cancer biosimilars, however, could present issues for oncologists. Practices may have to contend with potentially strong patient and physician aversion to switching from treatment using biologicals to biosimilars for cost-saving purposes, according to Dr Conti. In addition, because payer reimbursements are expected to be lower for biosimilars compared to originator biologicals, oncology practices may be reluctant to start new patients on biosimilars.

In fact, Professor Conti points to three additional, emerging challenges associated with biosimilar reimbursement:

1.   The US lacks payer infrastructure facilitating the automatic substitution of brand-name biologicals and biosimilars

      – Patients currently undergoing cancer treatment covered under their insurers’ pharmacy benefit will require new prescriptions from their physicians to be switched from biologicals to biosimilars.

       – Payers seem reluctant to use formulary utilization management strategies to promote the use of biosimilars.

       – As of 1 July 2017, 35 states and Puerto Rico have passed laws allowing substitution by a pharmacist if the biosimilar is considered interchangeable and is covered under an insurer’s pharmacy benefit [4]. However, despite issuing draft guidance on interchangeability in January 2017 [5], to date, FDA has yet to approve a biosimilar as interchangeable with its reference biological.

2.   The complex distribution chain for biologicals may hamper widespread use of biosimilars

       – Rebate agreements between drugmakers, pharmacy benefit managers, specialty pharmacies and insurers may create incentives that favour originator biologicals over biosimilars.

       – Makers of originator biologicals could threaten to withdraw rebates, effectively blocking biosimilar use.

3.   It is unclear to what extent biosimilar makers will challenge makers of originator biologicals in select therapeutic classes

– So-called pay-for-delay and other strategies have emerged as important threats to generics competition over the past decade and could threaten biosimilars competition in the same way.

– It is likely that patent disputes, the introduction of so-called authorized biosimilars, marketing activities and other business strategies that effectively block biosimilar competition may emerge over time.

These issues, according to Professor Conti, could place oncology practices ‘on the front lines of adjudicating whether to prescribe biosimilars to treat cancer’. She adds that ‘In the absence of payer pressure to substitute between biologicals and biosimilars, practices will need to respond to patient requests for the use of biosimilars to lower their out-of-pocket cost burden.’ They may also have to provide education to patients and prescribers and navigate their own financial incentives.

Professor Conti therefore believes that it is important to develop and use treatment guidelines from nationally recognized entities, such as American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network. She points to the fact that guidelines seem to have been critical to the successful experience of Europe in biosimilar adoption to date [6].

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

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

Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

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. Conti RM. Biosimilars: reimbursement issues in your oncology practice. J Oncol Pract.  2017;13(9_suppl):12s-14s.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi
4. Cauchi R. State laws and legislation related to biologic medications and substitution of biosimilars. National Conference of State Legislatures [homepage on the Internet]; [cited 2018 Jan 5]. Available from: www.ncsl.org/research/health/state-laws-and-legislation-related-tobiologic-medications-and-substitution-of-biosimilars.aspx
5. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability
6. Meek T. Nordic countries near complete switch to biosimilar Remicade. APM Health Europe [homepage on the Internet]; [cited 2018 Jan 5]. Available from: www.apmhealtheurope.com/Nordic-countries-near-complete-switch-to-biosimilar-Remicade-FS_47642.html

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