ACR asked for guidelines on biosimilar substitution

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At the US Food and Drug Administration’s (FDA) latest meeting on Biosimilar User Fee Act Reauthorization (BsUFA II), the American College of Rheumatology (ACR) asked FDA to create guidelines for biosimilar substitution.

Guidance V13F21

The BsUFA calls for biosimilars makers to pay fees annually to FDA in the same way as brand-name drugmakers do [1]. The BsUFA lasts for a five-year period. The current version will expire on 30 September 2017 and the new version will cover fiscal years 2018 to 2022.

FDA held a public meeting on 20 October 2016 at the agency’s White Oak Campus, New Hampshire, USA to discuss the reauthorization of the BsUFA. The aim of the meeting was to gather stakeholder feedback on FDA’s proposed recommendations for BsUFA reauthorization.

During the meeting, Dr Angus Worthing, incoming chair of the American College of Rheumatology’s (ACR) Government Affairs Committee, reiterated the ACR’s call for FDA to provide guidance on biosimilar substitution. He also recommended that FDA ‘include the biosimilar’s interchangeable status and clinical data’ in the product’s labelling. He added that to give physicians more confidence in biosimilars their labelling should ‘include as much information as possible to help providers make treatment decisions that are in the best interest of their patients’. The inclusion of clinical data on the label or via a hyperlink could do this, according to Dr Worthing.

Dr Worthing ‘stressed the patient safety risks posed by substitution of non-interchangeable biosimilars, as well as the importance of establishing safeguards to protect patients’. He cautioned that ‘substituting non-interchangeable biosimilars, especially without notifying the prescribing provider, poses uncertain safety risks to rheumatology patients due to the complexity of these drugs and the possibility of patients being forced to switch’.

FDA has outlined providing guidance on interchangeability as one of its commitments in its BsUFA II performance goals letter. However, draft guidance on the issue is not likely to be produced before the end of 2017 [2].

‘The ACR also urged Congress to provide funding to enhance the FDA’s capacity to review biosimilar therapies, in order to expedite the approval of safe and effective biosimilar therapies and more quickly realize their promised cost savings’, Dr Worthing said that ‘we also need to ensure that the FDA has all of the resources it needs to oversee the safe and effective introduction of biosimilars into the US healthcare system’.

The ACR supports the use of distinct names [3] and ‘transparent labelling’ for biosimilars. The issue of naming for biologicals, however, is a contentious one. Other advocates for distinct names include the Biologics Prescribers Collaborative (BPC) and the Alliance for Safe Biologic Medicines (ASBM). The Generic Pharmaceutical Association (GPhA), on the other hand, believes that different names could ‘erect barriers to patient access to new, more affordable medicines, and jeopardize their safety’. While the Academy of Managed Care Pharmacy (AMCP) said distinct names could result in ‘lower market adoption and cost-savings’ from biosimilars [4].

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Biosimilar User Fee Act reauthorization

1. GaBI Online - Generics and Biosimilars Initiative. Generic and biosimilar user fee recommendations sent to Congress []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 28]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars interchangeability guidance expected by end 2017 []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 28]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. US rheumatologists in favour of distinct names for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 28]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s guidance on naming biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 28]. Available from:

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Source: ACR, US FDA

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