Clinical Review

Biosimilars in Psoriasis: The Future or Not?

Cutis. 2017 February;99(2):116-120

Ms. Kellen is from Weill Cornell Medical College, New York, New York. Dr. Goldenberg is from the Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.

Ms. Kellen reports no conflict of interest. Dr. Goldenberg is a consultant for AbbVie Inc; Amgen Inc; Celgene Corporation; Eli Lilly and Company; Janssen Biotech, Inc; Novartis; and Sun Pharmaceutical Industries Ltd. He also is a speaker for AbbVie Inc; Celgene Corporation; Eli Lilly and Company; and Novartis.

Correspondence: Gary Goldenberg, MD, 5 E 98th St, 5th Floor, New York, NY 10029 (garygoldenbergmd@gmail.com).

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References

Information on biosimilars. US Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/. Updated May 10, 2016. Accessed July 5, 2016.
US Department of Health and Human Services. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry. Silver Spring, MD: US Food and Drug Administration; 2015.
McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28:313-321.
FDA approves Inflectra, a biosimilar to Remicade [news release]. Silver Spring, MD: US Food and Drug Administration; April 5, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm. Updated April 20, 2016. Accessed January 23, 2017.
FDA approves Erelzi, a biosimilar to Enbrel [news release]. Silver Spring, MD: US Food and Drug Administration; August 30, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm. Accessed January 23, 2017.
FDA approves Amjevita, a biosimilar to Humira [news release]. Silver Spring, MD: US Food and Drug Administration; September 23, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm. Accessed January 23, 2017.
Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: a Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation [published online June 26, 2014]. J Clin Pharmacol. 2015;55(suppl 3):S123-S132.
Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars [published online September 14, 2007]. Ann Oncol. 2008;19:411-419.
Puig L. Biosimilars and reference biologics: decisions on biosimilar interchangeability require the involvement of dermatologists [published online October 2, 2013]. Actas Dermosifiliogr. 2014;105:435-437.
Strober BE, Armour K, Romiti R, et al. Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know. J Am Acad Dermatol. 2012;66:317-322.
Falit BP, Singh SC, Brennan TA. Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers. Health Aff (Millwood). 2015;34:294-301.
Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605-1612.
Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613-1620.
Carretero Hernandez G, Puig L. The use of biosimilar drugs in psoriasis: a position paper. Actas Dermosifiliogr. 2015;106:249-251.
Regulation of Biological Products, 42 USC §262 (2013).
Ventola CL. Evaluation of biosimilars for formulary inclusion: factors for consideration by P&T committees. P T. 2015;40:680-689.
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, 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. 2015;18:82.
Strober B, Foley P, Philipp S, et al. Evaluation of efficacy and safety of ABP 501 in a phase 3 study in subjects with moderate to severe plaque psoriasis: 52-week results. J Am Acad Dermatol. 2016;74(5, suppl 1):AB249.
Momenta Pharmaceuticals announces positive top-line phase 3 results for M923, a proposed Humira (adalimumab) biosimilar [news release]. Cambridge, MA: Momenta Pharmaceuticals, Inc; November 29, 2016. http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=1001255. Accessed January 25, 2017.
Griffiths CE, Thaci D, Gerdes S, et al. The EGALITY study: a confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis [published online October 27, 2016]. Br J Dermatol. doi:10.1111/bjd.15152.
Vanderpuye-Orgle J, Zhao Y, Lu J, et al. Evaluating the economic burden of psoriasis in the United States [published online April 14, 2015]. J Am Acad Dermatol. 2015;72:961-967.
Brezinski EA, Dhillon JS, Armstrong AW. Economic burden of psoriasis in the United States: a systematic review. JAMA Dermatol. 2015;151:651-658.
Menter MA, Griffiths CE. Psoriasis: the future. Dermatol Clin. 2015;33:161-166.
Hackbarth GM, Crosson FJ, Miller ME. Report to the Congress: improving incentives in the Medicare program. Medicare Payment Advisory Commission, Washington, DC; 2009.
Lovenworth SJ. The new biosimilar era: the basics, the landscape, and the future. Bloomberg website. http://about.bloomberglaw.com/practitioner-contributions/the-new-biosimilar-era-the-basics-the-landscape-and-the-future. Published September 21, 2012. Accessed July 6, 2016.
Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6:469-478.
Calvo B, Zuniga L. The US approach to biosimilars: the long-awaited FDA approval pathway. BioDrugs. 2012;26:357-361.
Lucio SD, Stevenson JG, Hoffman JM. Biosimilars: implications for health-system pharmacists. Am J Health Syst Pharm. 2013;70:2004-2017.
Barriers to access attributed to formulary changes. Manag Care. 2012;21:41.

References

Information on biosimilars. US Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/. Updated May 10, 2016. Accessed July 5, 2016.
US Department of Health and Human Services. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry. Silver Spring, MD: US Food and Drug Administration; 2015.
McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28:313-321.
FDA approves Inflectra, a biosimilar to Remicade [news release]. Silver Spring, MD: US Food and Drug Administration; April 5, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm. Updated April 20, 2016. Accessed January 23, 2017.
FDA approves Erelzi, a biosimilar to Enbrel [news release]. Silver Spring, MD: US Food and Drug Administration; August 30, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm. Accessed January 23, 2017.
FDA approves Amjevita, a biosimilar to Humira [news release]. Silver Spring, MD: US Food and Drug Administration; September 23, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm. Accessed January 23, 2017.
Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: a Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation [published online June 26, 2014]. J Clin Pharmacol. 2015;55(suppl 3):S123-S132.
Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars [published online September 14, 2007]. Ann Oncol. 2008;19:411-419.
Puig L. Biosimilars and reference biologics: decisions on biosimilar interchangeability require the involvement of dermatologists [published online October 2, 2013]. Actas Dermosifiliogr. 2014;105:435-437.
Strober BE, Armour K, Romiti R, et al. Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know. J Am Acad Dermatol. 2012;66:317-322.
Falit BP, Singh SC, Brennan TA. Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers. Health Aff (Millwood). 2015;34:294-301.
Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605-1612.
Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613-1620.
Carretero Hernandez G, Puig L. The use of biosimilar drugs in psoriasis: a position paper. Actas Dermosifiliogr. 2015;106:249-251.
Regulation of Biological Products, 42 USC §262 (2013).
Ventola CL. Evaluation of biosimilars for formulary inclusion: factors for consideration by P&T committees. P T. 2015;40:680-689.
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, 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. 2015;18:82.
Strober B, Foley P, Philipp S, et al. Evaluation of efficacy and safety of ABP 501 in a phase 3 study in subjects with moderate to severe plaque psoriasis: 52-week results. J Am Acad Dermatol. 2016;74(5, suppl 1):AB249.
Momenta Pharmaceuticals announces positive top-line phase 3 results for M923, a proposed Humira (adalimumab) biosimilar [news release]. Cambridge, MA: Momenta Pharmaceuticals, Inc; November 29, 2016. http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=1001255. Accessed January 25, 2017.
Griffiths CE, Thaci D, Gerdes S, et al. The EGALITY study: a confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis [published online October 27, 2016]. Br J Dermatol. doi:10.1111/bjd.15152.
Vanderpuye-Orgle J, Zhao Y, Lu J, et al. Evaluating the economic burden of psoriasis in the United States [published online April 14, 2015]. J Am Acad Dermatol. 2015;72:961-967.
Brezinski EA, Dhillon JS, Armstrong AW. Economic burden of psoriasis in the United States: a systematic review. JAMA Dermatol. 2015;151:651-658.
Menter MA, Griffiths CE. Psoriasis: the future. Dermatol Clin. 2015;33:161-166.
Hackbarth GM, Crosson FJ, Miller ME. Report to the Congress: improving incentives in the Medicare program. Medicare Payment Advisory Commission, Washington, DC; 2009.
Lovenworth SJ. The new biosimilar era: the basics, the landscape, and the future. Bloomberg website. http://about.bloomberglaw.com/practitioner-contributions/the-new-biosimilar-era-the-basics-the-landscape-and-the-future. Published September 21, 2012. Accessed July 6, 2016.
Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6:469-478.
Calvo B, Zuniga L. The US approach to biosimilars: the long-awaited FDA approval pathway. BioDrugs. 2012;26:357-361.
Lucio SD, Stevenson JG, Hoffman JM. Biosimilars: implications for health-system pharmacists. Am J Health Syst Pharm. 2013;70:2004-2017.
Barriers to access attributed to formulary changes. Manag Care. 2012;21:41.

Biosimilars in Psoriasis: The Future or Not?

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