In late 2022, the American College of Rheumatology (ACR) issued a position statement on biosimilars [1] in which they emphasized their strong belief that safe and effective treatments should be available to patients at the lowest possible cost. This is an update of previous position statements [2].
ACR states that decisions regarding the approval and use of biosimilars should be approved based on sound science and they consider six observations and guiding principles:
1. Due to their size, complexity and heterogeneity, biologicals (and biosimilars) necessitate more scrutiny in their analytical evaluation than that required for small molecule generics.
2. Clinical data are necessary (in addition to adequate pharmacokinetic and pharmacodynamic studies) to ensure the safety and efficacy of biosimilars, and to allow patients and clinicians to be confident in their use. Long-term post-marketing data for each biosimilar is needed to monitor adverse events.
3. Post-marketing surveillance studies are needed in both children and adults. The Best Pharmaceuticals for Children Act (BPCA) should apply to biosimilars.
4. The US Food and Drug Administration (FDA) labels should clearly indicate whether a biosimilar is interchangeable with the reference biological. They should also clearly state all indications for which a biosimilar is approved and specify whether supporting clinical data for the indication are derived from studies of the biosimilar or the reference biological.
5. When starting new biological therapy, clinicians consider a variety of patient-specific factors which include severity of illness, the most appropriate route of administration and mechanism of action. The ACR supports initial biosimilar use if a biosimilar option of the appropriate treatment biological exists for a patient, however, if a biosimilar option is not available any switches should be approved by the patient insurer.
6. In patients on established therapy, decisions on switching to biosimilars should rest with the prescriber and the patient. The ACR opposes insurer-mandated forced switching to biosimilars and in jurisdictions where substitution by someone other than the prescriber is lawful, the prescriber should be notified upon substitution.
Overall, ACR is supportive of the use of biosimilars and the potential this has to make treatment options more affordable to patients. However, they believe that biosimilars must be administered based on the six points and that decisions regarding administration and switching should lie in the hands of the prescriber only.
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References
1. American College of Rheumatology. Biosimilars Position Statement [homepage on the Internet]. [cited 2023 Mar 16]. Available from: https://www.rheumatology.org/portals/0/files/biosimilars-position-statement.pdf
2. GaBI Online - Generics and Biosimilars Initiative. ACR position statement on biosimilars addresses naming and substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 16]. Available from:
www.gabionline.net/biosimilars/general/ACR-position-statement-on-biosimilars-addresses-naming-and-substitution
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