Tinsley SM, Grande C, Olson K, Plato L, Jacobs I. Potential of biosimilars to increase access to biologics: considerations for advanced practice providers in oncology. J Adv Pract Oncol. 2018;9(7):699. https://doi.org/10.6004/jadpro.2018.9.7.2.
Article PubMed PubMed Central Google Scholar
Antman EM, Creager MA, Houser SR, Warner JJ, Konig M. American Heart Association principles on the accessibility and affordability of drugs and biologics: a presidential advisory from the American Heart Association. Circulation. 2017;136(24):e441–7. https://doi.org/10.1161/CIR.0000000000000551.
Kirchhoff CF, Wang XZM, Conlon HD, Anderson S, Ryan AM, Bose A. Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 2017;114(12):2696–705. https://doi.org/10.1002/bit.26438.
Article CAS PubMed PubMed Central Google Scholar
Safdar A, Butt MH, Ahmad A, Zaman M. Progress in oncology biosimilars till 2020: scrutinizing comparative studies of biosimilar monoclonal antibodies. J Oncol Pharm Pract. 2021;27(5):1195–204. https://doi.org/10.1177/10781552211016083.
Triantafyllidi E, Triantafillidis JK. Systematic review on the use of biosimilars of trastuzumab in HER2+ breast cancer. Biomedicines. 2022;10(8):2045. https://doi.org/10.3390/biomedicines10082045.
Article CAS PubMed PubMed Central Google Scholar
Stebbing J, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, et al. Double-blind, randomized phase III study to compare the efficacy and safety of CT-P6, trastuzumab biosimilar candidate versus trastuzumab as neoadjuvant treatment in HER2 positive early breast cancer (EBC). J Clin Oncol. 2017. https://doi.org/10.1200/JCO.2017.35.15_suppl.510.
Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018;36(12):1260–5. https://doi.org/10.1200/jco.2017.77.4893.
Chen B, Nagai S, Armitage JO, Witherspoon B, Nabhan C, Godwin AC, et al. Regulatory and clinical experiences with biosimilar filgrastim in the U.S., the European Union, Japan, and Canada. Oncologist. 2019;24(4):537–48. https://doi.org/10.1634/theoncologist.2018-0341.
Article PubMed PubMed Central Google Scholar
Jensen TB, Kim SC, Jimenez-Solem E, Bartels D, Christensen HR, Andersen JT. Shift from adalimumab originator to biosimilars in Denmark. JAMA Intern Med. 2020;180(6):902–3. https://doi.org/10.1001/jamainternmed.2020.0338.
Article PubMed PubMed Central Google Scholar
Mouslim MC, Trujillo AJ, Alexander GC, Segal JB. Association between filgrastim biosimilar availability and changes in claim payments and patient out-of-pocket costs for biologic filgrastim products. Value Health. 2020;23(12):1599–605. https://doi.org/10.1016/j.jval.2020.06.014.
Article PubMed PubMed Central Google Scholar
Lobo F, Río-Álvarez I. Barriers to biosimilar prescribing incentives in the context of clinical governance in Spain. Pharmaceuticals (Basel). 2021;14(3):283. https://doi.org/10.3390/ph14030283.
Moorkens E, Godman B, Huys I, Hoxha I, Malaj A, Keuerleber S, et al. The expiry of Humira® market exclusivity and the entry of adalimumab biosimilars in Europe: an overview of pricing and national policy measures. Front Pharmacol. 2020;11: 591134. https://doi.org/10.3389/fphar.2020.591134.
Article CAS PubMed Google Scholar
Okoro RN. Biosimilar medicines uptake: the role of the clinical pharmacist. Explor Res Clin Soc Pharm. 2021;1: 100008. https://doi.org/10.1016/j.rcsop.2021.100008.
Article PubMed PubMed Central Google Scholar
Druedahl LC, Almarsdóttir AB, KälvemarkSporrong S, De Bruin ML, Hoogland H, Minssen T, et al. A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways. Nat Biotechnol. 2020;38(11):1253–6. https://doi.org/10.1038/s41587-020-0717-7.
Article CAS PubMed Google Scholar
Druedahl LC, KälvemarkSporrong S, van de Weert M, De Bruin MLM, Hoogland H, Minssen T, et al. Evolving biosimilar clinical requirements: a qualitative interview study with industry experts and European national medicines agency regulators. BioDrugs. 2021;35:351–61. https://doi.org/10.1007/s40259-021-00478-7.
Baumgart DC, Misery L, Naeyaert S, Taylor PC. Biological therapies in immune-mediated inflammatory diseases: can biosimilars reduce access inequities? Front Pharmacol. 2019;10:279. https://doi.org/10.3389/fphar.2019.00279.
Article CAS PubMed PubMed Central Google Scholar
Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014;73(1):198–206. https://doi.org/10.1136/annrheumdis-2012-202603.
Article CAS PubMed Google Scholar
Gershon N, Berchenko Y, Hall PS, Goldstein DA. Cost effectiveness and affordability of trastuzumab in sub-Saharan Africa for early stage HER2-positive breast cancer. Cost Effect Resour. 2019;17(1):1–10. https://doi.org/10.1186/s12962-019-0174-7.
Al-Ziftawi NH, Shafie AA, Mohamed Ibrahim MI. Cost-effectiveness analyses of breast cancer medications use in developing countries: a systematic review. Expert Rev Pharmacoecon Outcomes Res. 2021;21(4):655–66. https://doi.org/10.1080/14737167.2020.1794826.
Tubic B, Marković-Peković V, Jungić S, Allocati E, Godman B. Availability and accessibility of monoclonal antibodies in Bosnia and Herzegovina: findings and implications. Med Access Point Care. 2021;5: 23992026211027692. https://doi.org/10.1177/23992026211027692.
Article PubMed PubMed Central Google Scholar
Peyrin-Biroulet L, Lonnfors S, Avedano L, Danese S. Changes in inflammatory bowel disease patients’ perspectives on biosimilars: a follow-up survey. United Eur Gastroenterol. 2019;7(10):1345–52. https://doi.org/10.1177/2050640619883704.
Pineles D, Arsuaga A, Malter LB, Bosworth BP, Hudesman DP, Chang S. Patient perceptions regarding the use of biosimilars in inflammatory bowel disease. Am J Gastroenterol. 2017;112:S418–9. https://doi.org/10.14309/00000434-201710001-00750.
Fenwick S, Thakur K, Munro D. Nurse and patient perceptions and preferences for subcutaneous autoinjectors for inflammatory joint or bowel disease: findings from a European survey. Rheumatol Ther. 2019;6(2):195–206. https://doi.org/10.1007/s40744-019-0144-8.
Article PubMed PubMed Central Google Scholar
Sullivan E, Piercy J, Waller J, Black CM, Kachroo S. Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn’s disease across Germany. PLoS One. 2017;12(4): e0175826. https://doi.org/10.1371/journal.pone.0175826.
Article CAS PubMed PubMed Central Google Scholar
Smastuen MC, Brandvold M, Andenaes R. Is patients’ satisfaction with being switched to a biosimilar medication associated with their level of health literacy? Results from a Norwegian user survey. Ann Rheum Dis. 2018;77:86. https://doi.org/10.1136/annrheumdis-2018-eular.5993.
Young D, Cummings F, Latter S. Patient perspectives of successful adalimumab biosimilar transitioning in Crohn’s disease: an interview study. Eur J Hosp Pharm. 2022. https://doi.org/10.1136/ejhpharm-2022-003371.
Scherlinger M, Langlois E, Germain V, Schaeverbeke T. Acceptance rate and sociological factors involved in the switch from originator to biosimilar etanercept (SB4). Semin Arthritis Rheum. 2019;48(5):927–32. https://doi.org/10.1016/j.semarthrit.2018.07.005.
Gasteiger C, Scholz U, Petrie KJ, Dalbeth N. A bio-what? Medical companions’ perceptions towards biosimilars and information needs in rheumatology. Rheumatol Int. 2022;42(11):1993–2002. https://doi.org/10.1007/s00296-021-05037-5.
Frantzen L, Cohen J-D, Trope S, Beck M, Munos A, Sittler M-A, et al. Patients’ information and perspectives on biosimilars in rheumatology: a French nation-wide survey. Joint Bone Spine. 2019;86(4):491–6. https://doi.org/10.1016/j.jbspin.2019.01.001.
Kovitwanichkanont T, Raghunath S, Wang D, Kyi L, Pignataro S, Morton S, et al. Who is afraid of biosimilars? Openness to biosimilars in an Australian cohort of patients with rheumatoid arthritis. Intern Med J. 2020;50(3):374–7. https://doi.org/10.1111/imj.14753.
Wu Q, Lian Z, Wang X, Cheng H, Sun J, Yu H, et al. Factors associated with the uptake of biosimilars for breast cancer treatment from the perspectives of physicians and patients: evidence from China. Front Pharmacol. 2023. https://doi.org/10.3389/fphar.2022.1044798.
Article PubMed PubMed Central Google Scholar
Teeple A, Ginsburg S, Howard L, Huff L, Reynolds C, Walls D, et al. Patient attitudes about non-medical switching to biosimilars: results from an online patient survey in the United States. Curr Med Res Opin. 2019;35(4):603–9. https://doi.org/10.1080/03007995.2018.1560221.
Article CAS PubMed Google Scholar
Waller J, Sullivan E, Piercy J, Black CM, Kachroo S. Assessing physician and patient acceptance of infliximab biosimilars in rheumatoid arthritis, ankylosing spondyloarthritis and psoriatic arthritis across Germany. Patient Prefer Adher. 2017;11:519–30. https://doi.org/10.2147/ppa.S129333.
Mohd Sani N, Aziz Z, Panickar R, Kamarulzaman A. Pharmacists’ perspectives of biosimilars: a systematic review. BioDrugs. 2022;36(4):489–508. https://doi.org/10.1007/s40259-022-00541-x.
Comments (0)