The US Food and Drug Administration (FDA) received 52 comments on its draft guidance on the interchangeability of biosimilars with their reference biologicals.
The draft guidance was first released in January 2017 [1] and the comment period ended on 19 May 2017 [2]. Associations that commented on the guideline included the American College of Rheumatology (ACR), American Society of Clinical Oncology (ASCO), the American Gastroenterological Association (AGA), the American Academy of Dermatology Association (AADA), and the American Autoimmune Related Diseases Association (AARDA), among others.
Comments from physician associations expressed their concerns about extrapolation of indications, but other issues raised included switching, labelling and naming, post-marketing studies and disease experts [3].
1. Extrapolation
Extrapolation has long been a concern for both physicians and patients. Concerns raised included the pathophysiology of the drug and paediatric indications. Other comments raised the possibility of inappropriate substitution in cases where an interchangeable drug does not gain approval for all indications of the originator drug.
2. Switching
Comments on switching included support for the decision by FDA to use only US‐licensed reference products in switching studies, as well as support for the robust design of the switching studies proposed.
Concerns were, however, raised about the fact that this practice could ‘have a detrimental impact on patient safety’. Physician associations believe that healthcare providers should have the power to prevent switching ‘if they believe that the patient’s safety and health is at risk’ and should be notified when switching occurs. In addition, they state that ‘patients must be informed and educated about the substitution at the point of sale’.
It was also questioned ‘whether any biosimilar could be “interchangeable” with the reference product, particularly if autoimmune disease patients are considered’, due to the complexity of the disease.
3. Labelling and naming
Comments included requests for labelling to include distinct names, as well as statements about interchangeabilty (in addition to whether a drug is biosimilar) and data from clinical trials. Specific guidance for pharmacists to prevent inadvertent substitution of a non-interchangeable biosimilar was also requested.
4. Post-marketing studies
Physician associations believe that ‘real world’ data on biosimilar and interchangeable products must be collected through formal post-marketing observational studies to ensure the longitudinal safety and efficacy for all patient populations being treated with these products.
5. Disease experts
It was also suggested that ‘gastroenterologists with appropriate disease expertise should be engaged by the FDA when interchangeable products are reviewed for approval’.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability
2. GaBI Online - Generics and Biosimilars Initiative. FDA extends comment period for interchangeability guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Guidelines/FDA-extends-comment-period-for-interchangeability-guidance
3. Derbyshire M. Physician associations comment on FDA’s interchangeability guidance. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(3):120-1. doi:10.5639/gabij.2017.0603.024
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