To the Editor: The SAME study affirmed the safety and efficacy of switching between originator and biosimilars and the potential for cost savings.1 Yet the global uptake of biosimilars has been relatively slow2 due to a number of factors, including marketing suggesting that such drugs are less safe or efficacious than the originator.3 Implicated in such marketing is confusion arising from the use of the word “interchangeable”, which is a defined term under United States legislation. The word “substitution” is used in Australia, which raises the likelihood of further confusion.
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- 1. Haifer C, Srinivasan A, An Y‐K, et al. Switching Australian patients with moderate to severe inflammatory bowel disease from originator to biosimilar infliximab: a multicentre, parallel cohort study. Med J Aus 2021; 214: 128–133. https://www.mja.com.au/journal/2021/214/3/switching‐australian‐patients‐moderate‐severe‐inflammatory‐bowel‐disease
- 2. Lim D. Is Australia positioned to take advantage of biosimilars? GaBI J 2014; 3: 184–187.
- 3. Pfizer. Citizen petition. New York: Pfizer; 2018. https://www.regulations.gov/document/FDA‐2018‐P‐3281‐0001 (viewed Mar 2021).
- 4. Therapeutic Goods Administration. Biosimilar medicines regulation. Canberra: Department of Health; 2018. https://www.tga.gov.au/publication/biosimilar‐medicines‐regulation (viewed Sept 2021).
- 5. Baldry R, Lim D, Lau E, Nissen L. Doctors’, pharmacists’ and patients’ attitudes and perceptions about biosimilars: a systematic literature review. National Medicines Symposium 2016; Canberra, 19–20 May, 2016. Canberra: NPS MedicineWise; 2016.
No relevant disclosures.