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Review

Are biosimilars approved for use in psoriasis safe enough to replace leading biologic therapies? A review

ORCID Icon, , , &
Pages 459-466 | Received 10 Dec 2019, Accepted 28 Feb 2020, Published online: 09 Mar 2020

References

  • 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):1495–1502.
  • Carrascosa J, Jacobs I, Petersel D, et al. Biosimilar drugs for psoriasis: principles, present, and near future. Dermatol Ther. 2018;8(2):173–194.
  • Radtke MA, Augustin M. Biosimilars in psoriasis: what can we expect? J Dtsch Dermatol Ges. 2014;12(4):306–312.
  • Blauvelt A, Cohen AD, Puig L, et al. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol. 2016;174(2):282–286.
  • Moots R, Azevedo V, Coindreau JL, et al. Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the clinician. Curr Rheumatol Rep. 2017;19(37):1–16.
  • Zhao S, Chadwick L, Mysler E, et al. Review of biosimilar trials and data on adalimumab in rheumatoid arthritis. Curr Rheumatol Rep. 2018;20(10):57.
  • 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):1093–1102.
  • 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.
  • 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):1679–1687.
  • 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.
  • 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):914–921.
  • 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):3495–3497.
  • Efficacy, Safety, and Immunogenicity of BI 695501 versus Humira® in patients with moderate to severe chronic plaque psoriasis (Identification no: NCT02850965). cited 2019 Sept 18. Available from: https://clinicaltrials.gov/ct2/show/NCT02850965. Last updated: February 8, 2019.
  • 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):40–48.
  • 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):832–840.
  • 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):623–631.
  • 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):706–707.
  • 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):51–57.
  • 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):1986–1991.
  • Lund T, Sand C, Gniadecki R, et al. Effectiveness and safety of switching to biosimilar infliximab and etanercept in patients with psoriasis. Dermatol Ther. 2019;32(3):e12846.
  • 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):409–410.
  • 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):509–519.
  • 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):928–938.
  • 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):420–427.
  • 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.
  • 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.
  • 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):355–363.
  • 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):346–354.
  • 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):817–824.
  • 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):237–245.
  • 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–S168.
  • 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):2304–2316.
  • 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–e326.
  • 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.
  • 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;77:234–240.
  • 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.
  • Alten R, Tseluyko V, Hala T, et al. FRI0137 Efficacy, safety and immunogenicity from week 30 to week 54 in a randomised, double-blind phase iii study comparing a proposed infliximab biosimilar (PF-06438179/GP1111) with reference infliximab. Ann Rheum Dis. 2018;77:612.
  • US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product: guidance for industry. cited 2019 Dec 1. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf.

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