Volume 28, Issue 2 - Generics and biosimilars

Layperson materials in the sphere of biosimilars and generic medicines

Authors: David McMinn, Craig Scott, Baxter Jeffs

Abstract

Download the full article

References

1. Goel N, O’Sullivan D, Steinkoenig I, James J, Lindsay CA, Coates LC, et al., Tackling patient centricity: A report from the GRAPPA 2016 annual meeting. J Rheumatol. 2017;44:703–705; DOI: Available from: https://doi.org/10.3899/jrheum.170152.
2. Stegemann S, Ternik RL, Onder G, Khan MA, van Riet-Nales DA. Defining patient centric pharmaceutical drug product design. Amer Assoc Pharmac Sci J 2016;18:1047–55. Available from: https://doi.org/ 10.1208/s12248–016–9938–6.
3. Sacristan JA, Aguarón A, Avendaño-Solá C, Garrido P, Carrión J, Gutiérrez A, et al., Patient involvement in clinical research: why, when, and how. Pat Pref Adher. 2016;10:631–640.
4. Yeoman G, Furlong P, Seres M, Binder H, Chung H, Garzya V, et al., Defining patient centricity with patients for patients and caregivers: a collaborative endeavour. BMJ Innovations 2017;3:76–83.
5. Schindler T. The joys of the impossible: The writing of lay summaries of clinical study results. ClinicalTrialsArena [Internet]. 2016 December 20 [cited 2019 April 24]. Available at Available from: https://www.clinicaltrialsarena.com/news /the-joys-of-the-impossible-the-writing-oflay- summaries-of-clinical-study-results- 5697962–2/.
6. Gillow CL. Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance. Med Writ. 2015;24:205–209.
7. European Commission. Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. February 2018. Available at: Available from: https://ec.europa.eu/health/sites/health/ files/files/eudralex/vol-10/2017_01_26_ summaries_of_ct_results_for_laypersons. pdf.
8. Isaacs J, Gonçalves J, Strohal R, Castañeda- Hernández G, Azevedo V, Dörner T, et al., The biosimilar approval process: how different is it? Consider Med. 2017;1:doi: 10.1136/conmed-2017–100003.
9. Alrasheedy A, Hassali MA, Stewart K, Kong D, Aljadhey H, Ibrahim MIM, et al., Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature. Pat Intell. 2014;6:1–29.
10. Sanchez CK & Zurek AM. Patient perceptions of generic drugs: dispelling misconceptions. US Pharm. 2016;41 (Generic Drug Review suppl):36–41.