Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

Safety and Effectiveness of Anti-Tumor Necrosis Factor-Alpha Biosimilar Agents in the Treatment of Psoriasis

Abstract

Biologic drugs have revolutionized the treatment of psoriasis and other chronic inflammatory diseases. In recent years, many tumor necrosis factor-alpha ‘biosimilar’ agents have been developed. These biosimilars are similar in structure and function to their originator molecules, although they are not identical. Given that the safety and efficacy of the original biologic have already been proven, biosimilars are only required to show bioequivalence, or non-inferiority, to the reference biologic to be approved. Based on extrapolation of these non-inferiority data, biosimilars may be subsequently approved for all indications of the originator biologic, even without being directly studied in these various conditions. These biosimilar agents have been purported as a method to reduce the costs of biologic therapies, thereby increasing the accessibility of these medications and subsequently improving the treatment of psoriasis worldwide. The US Food and Drug Administration and/or the European Medicines Agency have approved biosimilars of adalimumab (Amjevita/Amgevita/Solymbic, Cyltezo, Imraldi/Hadlima, Hyrimoz/Hefiya/Halimatoz, Idacio, Hulio, Abrilada), etanercept (Erelzi, Benepali/Eticovo), and infliximab (Inflectra/Remsima, Renflexis/Flixabi, Ixifi/Zessly) for the treatment of psoriasis, and others are under review. There are many phase III data supporting the bioequivalence of these anti-tumor necrosis factor-alpha biosimilar agents in treating psoriasis and rheumatologic disease, which are discussed here. In general, these biosimilar agents have been shown to have equivalent efficacy, tolerability, and immunogenicity profiles compared to their originators in patients with rheumatologic disease, although studies in patients with psoriasis are fairly limited. Additional switching studies and post-marketing safety analyses are needed to assess the interchangeability of biosimilar agents with their reference products.

This is a preview of subscription content, log in to check access.

References

  1. 1.

    Cohen AD, Wu JJ, Puig L, et al. Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice. Br J Dermatol. 2017;177(6):1495–502.

  2. 2.

    Carrascosa J, Jacobs I, Petersel D, Strohal R. Biosimilar drugs for psoriasis: principles, present, and near future. Dermatol Ther. 2018;8(2):173–94.

  3. 3.

    Radtke MA, Augustin M. Biosimilars in psoriasis: what can we expect? Biosimilars in psoriasis. J Dtsch Dermatol Ges. 2014;12(4):306–12.

  4. 4.

    Simoens S. Biosimilar medicines and cost-effectiveness. Clinicoecon Outcomes Res. 2011;3:29–36.

  5. 5.

    Biosimilars Resources Center. What is a biobetter? https://www.biosimilarsresourcecenter.org/faq/what-is-a-biobetter/. Accessed 23 Sep 2019.

  6. 6.

    Generics and Biosimilars Initiative (GaBI). Biosimilars approved in Europe. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed 18 Dec 2019.

  7. 7.

    Generics and Biosimilars Initiative (GaBI). Biosimilars approved in the US. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US. Accessed 18 Dec 2019.

  8. 8.

    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.

  9. 9.

    Gooderham M, Spelman L, Kaliaperumal A, et al. Single transition from adalimumab to ABP 501: evaluation of immunogenicity in a phase 3 study in subjects with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;74(5 Suppl. 1):AB275.

  10. 10.

    Cohen SB, Genovese MC, Choy E, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017;76(10):1679–87.

  11. 11.

    Cohen SB, Pablos JL, Muller GA, et al. An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis. Arthritis Res Ther. 2019;21(1):84.

  12. 12.

    Cohen SB, Alonso-Ruiz A, Klimiuk PA, et al. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Ann Rheum Dis. 2018;77(6):914–21.

  13. 13.

    Cohen SB, Alonso-Ruiz A, Klimiuk PA, et al. Biosimilar candidate BI 695501 and adalimumab reference product have similar efficacy and safety in patients with moderately-to-severely active rheumatoid arthritis (RA): 1-year results from a phase III study. Arthritis Rheumatol. 2017;69(Suppl. 10):3495–7.

  14. 14.

    Efficacy, safety, and immunogenicity of BI 695501 versus Humira® in patients with moderate to severe chronic plaque psoriasis (identification no: NCT02850965). https://clinicaltrials.gov/ct2/show/NCT02850965. Last updated: February 8, 2019. Accessed 18 Dec 2019.

  15. 15.

    The VOLTAIRE-X trial looks at the effect of switching between Humira® and BI 695501 in patients with plaque psoriasis (identification no: NCT03210259). https://clinicaltrials.gov/ct2/show/results/NCT03210259. Last updated: October 11, 2019. Accessed 18 Dec 2019.

  16. 16.

    Weinblatt M, Baranauskaite A, Niebrzydowski J, et al. Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol. 2018;70(1):40–8.

  17. 17.

    Weinblatt M, Baranauskaite A, Dokoupilova E, et al. Switching from reference adalimumab to SB5 (adalimumab biosimilar) in patients with rheumatoid arthritis: fifty-two-week phase III randomized study results. Arthritis Rheumatol. 2018;70(6):832–40.

  18. 18.

    Blauvelt A, Lacour JP, Fowler JF. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol. 2018;179(3):623–31.

  19. 19.

    Wiland P, Jeka S, Dokoupilova E, et al. FRI0087 Efficacy, safety, and immunogenicity results of the switch from reference adalimumab (refadl) to Sandoz biosimilar adalimumab (gp2017, sdz-adl) from ADMYRA phase 3 study in patients with moderate-to-severe rheumatoid arthritis (RA). Ann Rheum Dis. 2019;78(Suppl. 2):706–7.

  20. 20.

    Hercogová J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ. AURIEL-PsO: a randomised, 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. 2019. https://doi.org/10.1111/bjd.18220(Epub ahead of print).

  21. 21.

    Edwards CJ, Monnet J, Ullmann M, Vlachos P, Chyrok V, Chori V. Safety of adalimumab in patients with moderately-to-severely active rheumatoid arthritis. Clin Rheumatol. 2019;38(12):3381–90.

  22. 22.

    Alten R, Glover J, Matsunaga N, Chisholm D, Genovese M. OP0021: efficacy and safety results of a phase III study comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017;76(Suppl. 2):59.

  23. 23.

    Fleischmann RM, Alten R, Pileckyte M, et al. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018;20(1):178.

  24. 24.

    Emery P, Vencovsky J, Sylwestrzak A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76(1):51–7.

  25. 25.

    Emery P, Vencovsky J, Sylwestrzak A, et al. Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4. Ann Rheum Dis. 2017;76(12):1986–91.

  26. 26.

    Lund T, Sand C, Gniadecki R, Thomsen SF. Effectiveness and safety of switching to biosimilar infliximab and etanercept in patients with psoriasis. Dermatol Ther. 2019;32(3):e12846.

  27. 27.

    Gisondi P, Bianchi L, Calzavara-Pinton P, et al. Etanercept biosimilar SB4 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry. Br J Dermatol. 2019;180(2):409–10.

  28. 28.

    Egeberg A, Ottosen MB, Gniadecki R, et al. Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2):509–19.

  29. 29.

    Giunta A, Manfreda V, Esposito M, Del Duca E, Bianchi L. Etanercept biosimilar SB4 in the treatment of plaque‐type psoriasis and psoriatic arthritis: a single‐centre, observational, retrospective, real‐life study. 2019 May 3. https://doi.org/10.1111/bjd.18090. (Epub ahead of print).

  30. 30.

    Griffiths CEM, Thaci D, Gerdes S, et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2017;176(4):928–38.

  31. 31.

    Gerdes S, Thaci D, Griffiths C, et al. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study. J Eur Acad Dermatol Venereol. 2018;32(3):420–7.

  32. 32.

    Matucci-Cerinic M, Allanore Y, Kavanaugh A, et al. Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study. RMD Open. 2018;4(2):e000757.

  33. 33.

    Yamanaka H, Kamatani N, Tanaka Y, et al. AB0416: a comparative study to assess the efficacy, safety, and immunogenicity of YLB113 and etanercept reference product for the treatment of patients with active rheumatoid arthritis. Ann Rheum Dis. 2019;78(Suppl. 2):A1670.

  34. 34.

    Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016;18:82.

  35. 35.

    Park W, Yoo DH, Jaworski J, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016;18:25.

  36. 36.

    Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017;76(2):355–63.

  37. 37.

    Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017;76(2):346–54.

  38. 38.

    Takeuchi T, Yamanaka H, Tanaka Y, et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2015;25(6):817–24.

  39. 39.

    Tanaka Y, Yamanaka H, Takeuchi T, et al. Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab. Mod Rheumatol. 2017;27(2):237–45.

  40. 40.

    Ye BD, Kim Y, Pesegova M, et al. 814: phase III randomized controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn’s disease: 1-year maintenance and switching results. Gastroenterol. 2018;154(6):S167–8.

  41. 41.

    Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304–16.

  42. 42.

    Dapavo P, Vujic I, Fierro MT, Quaglino P, Sanlorenzo M. The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75(4):736–9.

  43. 43.

    Ricceri F, Pescitelli L, Lazzeri L, Prignano F. Clinical experience with infliximab biosimilar in psoriasis. Br J Dermatol. 2017;177(6):e347–8.

  44. 44.

    Gisondi P, Bianchi L, Conti A, et al. Infliximab biosimilar CT-P13 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry. Br J Dermatol. 2017;177(6):e325–6.

  45. 45.

    Panagakis P, Rompoti N, Stravodimou A, Papoutsaki M, Rigopoulos D. Efficacy and safety of infliximab biosimilar in the treatment of moderate-to-severe plaque psoriasis: a 52-week clinical study. J Am Acad Dermatol. 2019;81(4):AB198.

  46. 46.

    Choe JY, Prodanovic N, Niebrzydowski J, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76(1):58–64.

  47. 47.

    Smolen JS, Choe J, Prodanovic N, et al. Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study. Ann Rheum Dis. 2018;77:234–40.

  48. 48.

    Cohen SB, Alten R, Kameda H, et al. A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. Arthritis Res Ther. 2018;20(1):155.

  49. 49.

    Genovese MC, Sanchez-Burson J, Oh M, et al. AB0377: clinical similarity of ABP 710 with infliximab (reference product) in subjects with moderate to severe rheumatoid arthritis. Ann Rheum Dis. 2019;78(Suppl. 2):A1648.

  50. 50.

    Shai MZ, Sarpatwari A, Kesselheim AS. Why are biosimilars not living up to their promise in the US? AMA J Ethics. 2019;21(8):E668–78.

  51. 51.

    Chen BK, Yang YT, Bennett CL. Why biologics and biosimilars remain so expensive: despite two wins for biosimilars, the Supreme Court’s recent rulings do not solve fundamental barriers to competition. Drugs. 2018;78(17):1777–81.

  52. 52.

    McKinnon RA, Cook M, Liauw W, Marabani M, Marschner IC, Packer NH, et al. Biosimilarity and interchangeability: principles and evidence: a systematic review. BioDrugs. 2018;32(1):27–52.

  53. 53.

    US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product: guidance for industry. 2019. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Accessed 18 Dec 2019.

Download references

Author information

Correspondence to Jashin J. Wu.

Ethics declarations

Funding

No sources of funding were received for the preparation of this article.

Conflict of interest

Jashin J. Wu is an investigator for AbbVie, Amgen, Eli Lilly, Janssen, and Novartis; a consultant for AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Promius Pharma, Regeneron, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America LLC; and a speaker for AbbVie, Celgene, Novartis, Regeneron, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America LLC. Wilson Liao has received research grant funding from Abbvie, Amgen, Janssen, Novartis, Pfizer, Regeneron, and TRex Bio. Kelly A. Reynolds, Deeti J. Pithadia, and Erica B. Lee have no conflicts of interest that are directly relevant to the content of this article.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Reynolds, K.A., Pithadia, D.J., Lee, E.B. et al. Safety and Effectiveness of Anti-Tumor Necrosis Factor-Alpha Biosimilar Agents in the Treatment of Psoriasis. Am J Clin Dermatol (2020). https://doi.org/10.1007/s40257-020-00507-1

Download citation