BIOSIMILARI ZA LIJEČENJE PSORIJAZE ODOBRENI U EVROPI
Ključne reči:
Ključne reči: biosimilari; biološki lekovi; psorijaza; efikasnost; sigurnos; EMA.
Sažetak
Poslednjih decenija, biološke terapije su se pojavile kao ključne komponente u terapijskom armamentarijumu, donoseći revolucionarne napredke u upravljanju različitim bolestima, uključujući hronični inflamatorni poremećaj kože, psorijazu. Biosimilari dizajnirani da blisko oponašaju, ali ne i repliciraju postojeće referentne biološke lekove, najavili su seizmičku promenu u pružanju zdravstvene zaštite, obećavajući jednak pristup inovativnim terapijama, uz podsticanje konkurencije na farmaceutskom tržištu.
Pojava biosimilara je demokratizovala pristup efikasnim tretmanima, ublažavajući finansijski teret kako za zdravstvene sisteme tako i za pacijente, posebno za stanja kao što je psorijaza, ozloglašena po prevelikim troškovima lečenja. Međutim, uprkos njihovom širokom usvajanju i značajnim obećanjima, i dalje postoje značajni izazovi, koji zahtevaju stalna istraživanja kako bi se sveobuhvatno ispitala njihova klinička efikasnost, bezbednosni profili i dugoročni rezultati.
Ovaj pregled ima cilj da prikaže sve do sada odobrene biosimilare u Evropi, sa posebnim osvrtom na etičke principe primene biosimilara.
Biosimilari predstavljaju transformativnu silu u savremenoj zdravstvenoj zaštiti, ali njihova optimalna integracija zahteva pažljiv nadzor, robusne mehanizme farmakovigilance i stalne istraživačke inicijative kako bi se osigurala bezbednost pacijenata, stvorilo poverenje među pružaocima zdravstvenih usluga i maksimizirala efikasnost lečenja kod pojedinaca koji se bore sa psorijazom i drugim hroničnim bolestima.
Reference
1. Carrascosa JM, Jacobs I, Petersel D, et al. Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future. Dermatol Ther (Heidelb). 2018; 8(2): 173-94.
2. Reynolds KA, Pithadia DJ, Lee EB, et al. Are biosimilars approved for use in psoriasis safe enough to replace leading biologic therapies? A review. Expert Opin Drug Saf. 2020; 19(4): 459-66.
3. Sciberras J, Zammit R, Vella Bonanno P, et al. The European framework for intellectual property rights for biological medicines. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021; 10(4): 172-83.
4. European Medicines Agency. Biosimilar medicines: Overview https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview Accessed 28 February 2024.
5. Generics and Biosimilars Initiative (GaBI). Biosimilars approved in Europe. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe Accessed 1 May 2024.
6. Generics and Biosimilars Initiative (GaBI). Biosimilars approved in the US. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us Accessed 1 May 2024.
7. Papp K, Bachelez H, Costanzo A, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol. 2017; 76(6): 1093–102.
8. Giunta A, Zangrilli A, Bavetta M, et al. A single-centre, observational, retrospective, real-life study evaluating adalimumab biosimilar ABP 501 in the treatment of plaque-type psoriasis and psoriatic arthritis in originator-naïve patients and in patients undergoing non-medical switch from originator. Curr Med Res Opin. 2021;37(7): 1099-102.
9. Lee A, Shirley M. PF-06410293: An Adalimumab Biosimilar. BioDrugs. 2020; 34(5): 695-8.
10. Blauvelt A, Lacour JP, Fowler JF, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol. 2018; 179(3): 623–31.
11. Wynne C, Schwabe C, Lemech C, et al. A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST). Expert Opin Investig Drugs 2022; 31: 965–76.
12. Feldman SR, Reznichenko N, Pulka G et al. Efficacy, safety and immunogenicity of AVT02 versus originator adalimumab in subjects with moderate to severe chronic plaque psoriasis: a multicentre, double-blind, randomized, parallel group, active control, phase III study. BioDrugs. 2021;35(6): 735–48
13. Al-Salama ZT. FKB327: An Adalimumab Biosimilar. BioDrugs. 2019;33(1): 113-6.
14. Hercogova J, Papp KA, Chyrok V, et al.. AURIEL-PsO: a randomized, double-blind phase III ´ equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br. J. Dermatol. 2020;182(2): 316–26.
15. Prignano F, Choi J, Pieper B, et al. Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars. Expert Opin Biol Ther. 2021;21: 75–80.
16. Barker J, Girolomoni G, Egeberg A, et al.. Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience. J Dermatolog Treat. 2020;31: 794–800.
17. Haranaka M, Tanaka T, Kim S, et al. Pharmacokinetics and safety of CT-P17 (40 mg/0.4 ml) versus reference adalimumab: randomized study in healthy Japanese adults. Immunotherapy. 2023; 15(3): 149-61.
18. Pan A, Gerriets V. Etanercept. In: StatPearls. Treasure Island (FL): StatPearls Publishing; July 24, 2023.
19. Gherghescu I, Delgado-Charro MB. The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. Pharmaceutics. 2020; 13(1): 48.
20. Cho IH, Lee N, Song D, et al. Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept. MAbs. 2016; 8(6): 1136-55.
21. Burness CB, Duggan ST. Erratum to: Etanercept (SB4): A Review in Autoimmune Inflammatory Diseases. BioDrugs. 2016; 30(5): 481.
22. Glintborg B, Loft AG, Omerovic E, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019; 78(2): 192-200.
23. Deeks ED. Correction to: GP2015: An Etanercept Biosimilar. BioDrugs. 2018;32(5): 525.
24. Piaserico S, Conti A, Messina F, et al. Cross-Switch from Etanercept Originator to Biosimilar SB4 and to GP2015 in Patients with Chronic Plaque Psoriasis. BioDrugs. 2021; 35(4): 469-71.
25. Yamanaka H, Kamatani N, Tanaka Y, et al. A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis. Rheumatol Ther. 2020; 7(1):149-63.
26. Yamanaka H, Tanaka Y, Hibino T, et al. Lower injection-site reactions and long-term safety, immunogenicity, and efficacy of etanercept biosimilar YLB113: Results from a post-hoc analysis of a double-blind, randomized, phase III comparative study and its open-label extension in patients with rheumatoid arthritis. Int J Rheum Dis. 2023;26(1):108-15.
27. Agboton C, Salameh J. Biosimilars in chronic inflammatory diseases: facts and remaining questions 5 years after their introduction in Europe. Expert Opin Biol Ther. 2022; 22(2): 157-67.
28. Jung EH, Sarpatwari A, Kesselheim AS, et al.. FDA and EMA Biosimilar Approvals [published correction appears in J Gen Intern Med. 2019 Dec 5;:]. J Gen Intern Med. 2020; 35(6): 1908-10.
29. Macaluso FS, Cummings JF, Atreya R, et al.. A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence. Expert Opin Biol Ther. 2022; 22(2): 203-23.
30. Kim DW, Lee Y, Kim G, et al. Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea. Adv Ther. 2023; 40(3): 1047-61.
31. Pagnini C, Di Paolo MC, De Angelis G, et al. Similar But Not Identical: Plaque Psoriasis Exacerbation in a Patient With Crohn's Disease After Switching From CT-P13 to SB2 Infliximab Biosimilar. Inflamm Bowel Dis. 2020; 26(8): 83-4.
32. European Medicines Agency. Remsima: European Public Assessment Report—summary for the public. 2013. https://www.ema.europa.eu/en/medicines/human/EPAR/remsima#ema-inpage-item-authorisation-details Accessed 28 February 2024.
33. Goll GL, Jørgensen KK, Sexton J, et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J Intern Med. 2019; 285(6): 653-69.
34. Kurizky PS, Galvão LO, Martins GA. Efficacy and safety of biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis: 1-year follow-up. An Bras Dermatol. 2019; 94(4): 483-4.
35. Morita A, Nishikawa K, Yamada F, et al. Safety, efficacy, and drug survival of the infliximab biosimilar CT-P13 in post-marketing surveillance of Japanese patients with psoriasis. J Dermatol. 2022;49(10):957-69.
36. McClellan JE, Conlon HD, Bolt MW, et al. The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product. Therap Adv Gastroenterol. 2019; 12: 1756284819852535.
37. Blauvelt A, Chiricozzi A. The immunologic role of IL-17 in psoriasis and psoriatic arthritis pathogenesis. Clin Rev Allergy Immunol. 2018;55(3):379-90.
38. Langley RG, Lebwohl M, Krueger GG, et al. Long-term efficacy and safety of ustekinumab, with and without dosing adjustment, in patients with moderate-to-severe psoriasis: results from the PHOENIX 2 study through 5 years of follow-up. Br J Dermatol. 2015; 172(5): 1371-83.
39. Hayashi M, Umezawa Y, Fukuchi O, et al. Efficacy and safety of ustekinumab treatment in elderly patients with psoriasis. J Dermatol. 2014; 41(11): 974-80.
40. Feldman SR, Reznichenko N, Berti F, et al. Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Expert Opin Biol Ther. 2023; 23(8): 759-71.
41. Derzi M, Shoieb AM, Ripp SL, et al. Comparative nonclinical assessments of the biosimilar PF-06410293 and originator adalimumab. Regul Toxicol Pharmacol. 2020; 112: 104587.
42. Genovese MC, Glover J, Greenwald M, et al. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension. Arthritis Res Ther. 2019; 21(1): 281.
43. Rémuzat C, Dorey J, Cristeau O, et al. Key drivers for market penetration of biosimilars in Europe. J Mark Access Health Policy. 2017; 5(1): 1272308.
44. Generics and Biosimilars Initiative (GaBI). The sluggish US biosimilars https://www.gabionline.net/reports/The-sluggish-US-biosimilars-market Accessed 2 May 2024.
45. Aladul MI, Fitzpatrick RW, Chapman SR. Impact of infliximab and etanercept biosimilars on biological disease-modifying antirheumatic drugs utilisation and NHS budget in the UK. Biodrugs. 2017; 31: 533–44.
46. Ravasio R, Girolomoni G, Gorla R. Analisi di budget impact del biosimilare di etanercept: lo scenario italiano. Glob. Reg. Health Technol. Assess. 2018; 2018; 1–12.
47. Loft N, Egeberg A, Rasmussen MK, et al. Outcomes Following a Mandatory Nonmedical Switch From Adalimumab Originator to Adalimumab Biosimilars in Patients With Psoriasis. JAMA Dermatol. 2021; 157(6): 676-83.
48. Gisondi P, Virga C, Piaserico S, et al. Switching from one infliximab biosimilar (CT-P13) to another infliximab biosimilar (SB2) in patients with chronic plaque psoriasis. Br J Dermatol. 2020; 183(2): 397-8.
49. Ruda RC, Kelly KA, Feldman SR. Real-world outcomes following switching from anti-TNF reference products to biosimilars for the treatment of psoriasis. J Dermatolog Treat. 2023; 34(1): 2140569.
50. Panahi M, Skelly Y, Zaman R. The effect of biosimilar administration on clinical outcomes in patients with adalimumab-controlled psoriasis. Skin Health Dis. 2021; 1(4): 60.
51. Teeple A, Ginsburg S, Howard L, 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): 1-7.
52. Varma M, Almarsdóttir AB, Druedahl LC. “Biosimilar, so it looks alike, but what does it mean?” A qualitative study of Danish patients' perceptions of biosimilars. Basic Clin Pharmacol Toxicol. 2022; 130(5): 581-91.
2. Reynolds KA, Pithadia DJ, Lee EB, et al. Are biosimilars approved for use in psoriasis safe enough to replace leading biologic therapies? A review. Expert Opin Drug Saf. 2020; 19(4): 459-66.
3. Sciberras J, Zammit R, Vella Bonanno P, et al. The European framework for intellectual property rights for biological medicines. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021; 10(4): 172-83.
4. European Medicines Agency. Biosimilar medicines: Overview https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview Accessed 28 February 2024.
5. Generics and Biosimilars Initiative (GaBI). Biosimilars approved in Europe. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe Accessed 1 May 2024.
6. Generics and Biosimilars Initiative (GaBI). Biosimilars approved in the US. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us Accessed 1 May 2024.
7. Papp K, Bachelez H, Costanzo A, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol. 2017; 76(6): 1093–102.
8. Giunta A, Zangrilli A, Bavetta M, et al. A single-centre, observational, retrospective, real-life study evaluating adalimumab biosimilar ABP 501 in the treatment of plaque-type psoriasis and psoriatic arthritis in originator-naïve patients and in patients undergoing non-medical switch from originator. Curr Med Res Opin. 2021;37(7): 1099-102.
9. Lee A, Shirley M. PF-06410293: An Adalimumab Biosimilar. BioDrugs. 2020; 34(5): 695-8.
10. Blauvelt A, Lacour JP, Fowler JF, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol. 2018; 179(3): 623–31.
11. Wynne C, Schwabe C, Lemech C, et al. A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST). Expert Opin Investig Drugs 2022; 31: 965–76.
12. Feldman SR, Reznichenko N, Pulka G et al. Efficacy, safety and immunogenicity of AVT02 versus originator adalimumab in subjects with moderate to severe chronic plaque psoriasis: a multicentre, double-blind, randomized, parallel group, active control, phase III study. BioDrugs. 2021;35(6): 735–48
13. Al-Salama ZT. FKB327: An Adalimumab Biosimilar. BioDrugs. 2019;33(1): 113-6.
14. Hercogova J, Papp KA, Chyrok V, et al.. AURIEL-PsO: a randomized, double-blind phase III ´ equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br. J. Dermatol. 2020;182(2): 316–26.
15. Prignano F, Choi J, Pieper B, et al. Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars. Expert Opin Biol Ther. 2021;21: 75–80.
16. Barker J, Girolomoni G, Egeberg A, et al.. Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience. J Dermatolog Treat. 2020;31: 794–800.
17. Haranaka M, Tanaka T, Kim S, et al. Pharmacokinetics and safety of CT-P17 (40 mg/0.4 ml) versus reference adalimumab: randomized study in healthy Japanese adults. Immunotherapy. 2023; 15(3): 149-61.
18. Pan A, Gerriets V. Etanercept. In: StatPearls. Treasure Island (FL): StatPearls Publishing; July 24, 2023.
19. Gherghescu I, Delgado-Charro MB. The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. Pharmaceutics. 2020; 13(1): 48.
20. Cho IH, Lee N, Song D, et al. Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept. MAbs. 2016; 8(6): 1136-55.
21. Burness CB, Duggan ST. Erratum to: Etanercept (SB4): A Review in Autoimmune Inflammatory Diseases. BioDrugs. 2016; 30(5): 481.
22. Glintborg B, Loft AG, Omerovic E, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019; 78(2): 192-200.
23. Deeks ED. Correction to: GP2015: An Etanercept Biosimilar. BioDrugs. 2018;32(5): 525.
24. Piaserico S, Conti A, Messina F, et al. Cross-Switch from Etanercept Originator to Biosimilar SB4 and to GP2015 in Patients with Chronic Plaque Psoriasis. BioDrugs. 2021; 35(4): 469-71.
25. Yamanaka H, Kamatani N, Tanaka Y, et al. A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis. Rheumatol Ther. 2020; 7(1):149-63.
26. Yamanaka H, Tanaka Y, Hibino T, et al. Lower injection-site reactions and long-term safety, immunogenicity, and efficacy of etanercept biosimilar YLB113: Results from a post-hoc analysis of a double-blind, randomized, phase III comparative study and its open-label extension in patients with rheumatoid arthritis. Int J Rheum Dis. 2023;26(1):108-15.
27. Agboton C, Salameh J. Biosimilars in chronic inflammatory diseases: facts and remaining questions 5 years after their introduction in Europe. Expert Opin Biol Ther. 2022; 22(2): 157-67.
28. Jung EH, Sarpatwari A, Kesselheim AS, et al.. FDA and EMA Biosimilar Approvals [published correction appears in J Gen Intern Med. 2019 Dec 5;:]. J Gen Intern Med. 2020; 35(6): 1908-10.
29. Macaluso FS, Cummings JF, Atreya R, et al.. A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence. Expert Opin Biol Ther. 2022; 22(2): 203-23.
30. Kim DW, Lee Y, Kim G, et al. Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea. Adv Ther. 2023; 40(3): 1047-61.
31. Pagnini C, Di Paolo MC, De Angelis G, et al. Similar But Not Identical: Plaque Psoriasis Exacerbation in a Patient With Crohn's Disease After Switching From CT-P13 to SB2 Infliximab Biosimilar. Inflamm Bowel Dis. 2020; 26(8): 83-4.
32. European Medicines Agency. Remsima: European Public Assessment Report—summary for the public. 2013. https://www.ema.europa.eu/en/medicines/human/EPAR/remsima#ema-inpage-item-authorisation-details Accessed 28 February 2024.
33. Goll GL, Jørgensen KK, Sexton J, et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J Intern Med. 2019; 285(6): 653-69.
34. Kurizky PS, Galvão LO, Martins GA. Efficacy and safety of biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis: 1-year follow-up. An Bras Dermatol. 2019; 94(4): 483-4.
35. Morita A, Nishikawa K, Yamada F, et al. Safety, efficacy, and drug survival of the infliximab biosimilar CT-P13 in post-marketing surveillance of Japanese patients with psoriasis. J Dermatol. 2022;49(10):957-69.
36. McClellan JE, Conlon HD, Bolt MW, et al. The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product. Therap Adv Gastroenterol. 2019; 12: 1756284819852535.
37. Blauvelt A, Chiricozzi A. The immunologic role of IL-17 in psoriasis and psoriatic arthritis pathogenesis. Clin Rev Allergy Immunol. 2018;55(3):379-90.
38. Langley RG, Lebwohl M, Krueger GG, et al. Long-term efficacy and safety of ustekinumab, with and without dosing adjustment, in patients with moderate-to-severe psoriasis: results from the PHOENIX 2 study through 5 years of follow-up. Br J Dermatol. 2015; 172(5): 1371-83.
39. Hayashi M, Umezawa Y, Fukuchi O, et al. Efficacy and safety of ustekinumab treatment in elderly patients with psoriasis. J Dermatol. 2014; 41(11): 974-80.
40. Feldman SR, Reznichenko N, Berti F, et al. Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Expert Opin Biol Ther. 2023; 23(8): 759-71.
41. Derzi M, Shoieb AM, Ripp SL, et al. Comparative nonclinical assessments of the biosimilar PF-06410293 and originator adalimumab. Regul Toxicol Pharmacol. 2020; 112: 104587.
42. Genovese MC, Glover J, Greenwald M, et al. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension. Arthritis Res Ther. 2019; 21(1): 281.
43. Rémuzat C, Dorey J, Cristeau O, et al. Key drivers for market penetration of biosimilars in Europe. J Mark Access Health Policy. 2017; 5(1): 1272308.
44. Generics and Biosimilars Initiative (GaBI). The sluggish US biosimilars https://www.gabionline.net/reports/The-sluggish-US-biosimilars-market Accessed 2 May 2024.
45. Aladul MI, Fitzpatrick RW, Chapman SR. Impact of infliximab and etanercept biosimilars on biological disease-modifying antirheumatic drugs utilisation and NHS budget in the UK. Biodrugs. 2017; 31: 533–44.
46. Ravasio R, Girolomoni G, Gorla R. Analisi di budget impact del biosimilare di etanercept: lo scenario italiano. Glob. Reg. Health Technol. Assess. 2018; 2018; 1–12.
47. Loft N, Egeberg A, Rasmussen MK, et al. Outcomes Following a Mandatory Nonmedical Switch From Adalimumab Originator to Adalimumab Biosimilars in Patients With Psoriasis. JAMA Dermatol. 2021; 157(6): 676-83.
48. Gisondi P, Virga C, Piaserico S, et al. Switching from one infliximab biosimilar (CT-P13) to another infliximab biosimilar (SB2) in patients with chronic plaque psoriasis. Br J Dermatol. 2020; 183(2): 397-8.
49. Ruda RC, Kelly KA, Feldman SR. Real-world outcomes following switching from anti-TNF reference products to biosimilars for the treatment of psoriasis. J Dermatolog Treat. 2023; 34(1): 2140569.
50. Panahi M, Skelly Y, Zaman R. The effect of biosimilar administration on clinical outcomes in patients with adalimumab-controlled psoriasis. Skin Health Dis. 2021; 1(4): 60.
51. Teeple A, Ginsburg S, Howard L, 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): 1-7.
52. Varma M, Almarsdóttir AB, Druedahl LC. “Biosimilar, so it looks alike, but what does it mean?” A qualitative study of Danish patients' perceptions of biosimilars. Basic Clin Pharmacol Toxicol. 2022; 130(5): 581-91.
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