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      Wednesday, June 7, 2023
      News & Perspective Drugs & Diseases CME & Education Academy Video Decision Point
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      CME / ABIM MOC / CE

      Test Your Skill: Incorporating Biosimilars Into the Management of Patients With Immunological Conditions

      • Authors: Steven Feldman, MD, PhD
      • CME / ABIM MOC / CE Released: 6/15/2022
      • Valid for credit through: 6/15/2023
      Start Activity

      • Credits Available

        Physicians - maximum of 1.00 AMA PRA Category 1 Credit(s)™

        ABIM Diplomates - maximum of 1.00 ABIM MOC points

        Nurses - 1.00 ANCC Contact Hour(s) (1 contact hours are in the area of pharmacology)

        Pharmacists - 1.00 Knowledge-based ACPE (0.100 CEUs)

        You Are Eligible For

        • Letter of Completion
        • ABIM MOC points

      Target Audience and Goal Statement

      This activity is intended for rheumatologists, gastroenterologists,  dermatologists, nurses, nurse practitioners, pharmacists, and other healthcare professionals who work with similar disease states.

      The goal of this activity is that learners will be better able to create customized care plans that include biosimilar agents for patients with immunological conditions. ​

      Upon completion of this activity, participants will:

      • Have increased knowledge regarding the
        • Characteristics that guide biosimilar selection for patients with immunological conditions
      • Have greater competence related to
        • Creating a customized care plan for patients that includes a biosimilar
      • Have improved performance associated with
        • Creating a customized care plan for patients that includes a biosimilar

      Disclosures

      Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

      All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated according to Medscape policies. Others involved in the planning of this activity have no relevant financial relationships.

      Faculty

      • Steven Feldman, MD, PhD

        Professor of Dermatology
        Wake Forest School of Medicine
        Winston-Salem, North Carolina

        Disclosures

        Steven Feldman, MD, PhD, has the following relevant financial relationships:
        Consultant or advisor for: AbbVie, Inc.; Accordant; Almirall; Alvotech; Amgen, Inc.; Arcutis; argenx; Arena Pharmaceuticals, Inc.; Biocon; Bristol Myers Squibb Company; Boehringer Ingelheim Pharmaceuticals, Inc.; Dermavant Sciences, Inc.; Forte; Galderma Laboratories, L.P.; Helsinn Therapeutics, Inc; Janssen; LEO Pharma, Inc.; Mylan Laboratories Inc.; Novartis; Pfizer Inc.; Samsung; Sanofi; UCB Pharma, Inc.; Sun Pharmaceutical Industries, Ltd; vTv Therapeutics
        Speaker or member of speakers bureau for: AbbVie, Inc.; Alvotech; Amgen, Inc.; Janssen; Lilly; Regeneron Pharmaceuticals, Inc.; Sanofi; Sun Pharmaceutical Industries, Ltd
        Research funding from: AbbVie; Almirall; Galderma Laboratories, L.P.; Janssen; Lilly; Pfizer Inc.; UCB Pharma, Inc.
        Stock options from: Sensal Health

      Editors

      • Christina T. Loguidice, BA

        Medical Education Director, Medscape, LLC

        Disclosures

        Christina T. Loguidice, BA, has no relevant financial relationships.

      • Megan Breuer, PhD

        Medical Writer, Medscape, LLC

        Disclosures

        Megan Breuer, PhD, has the following relevant financial relationships: Consultant/advisor for Paratek Pharmaceuticals, Inc (former)

      Compliance Reviewer/Nurse Planner

      • Leigh Schmidt, MSN, RN, CMSRN, CNE, CHCP

        Associate Director, Accreditation and Compliance, Medscape, LLC

        Disclosures

        Disclosure: Leigh Schmidt, MSN, RN, CMSRN, CNE, CHCP, has no relevant financial relationships.

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      In support of improving patient care, Medscape, LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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        Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Aggregate participant data will be shared with commercial supporters of this activity.

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      This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 75% on the post-test.

      Follow these steps to earn CME/CE credit*:

      1. Read the target audience, learning objectives, and author disclosures.
      2. Study the educational content online or printed out.
      3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

      You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

      *The credit that you receive is based on your user profile.

      < Navigating the Maze: Expert Guidance on Understanding and Integrating Biosimilars in Practice
      From Medscape Education Oncology
      CME / ABIM MOC / CE

      Test Your Skill: Incorporating Biosimilars Into the Management of Patients With Immunological Conditions

      Authors: Steven Feldman, MD, PhDFaculty and Disclosures

      CME / ABIM MOC / CE Released: 6/15/2022

      Valid for credit through: 6/15/2023

      processing....

      References

      1. Armstrong AW, et al. Psoriasis prevalence in adults in the United States. JAMA Dermatol. 2021;157:940-946.
      2. Fotiadou C, et al. Scalp psoriasis and biologic agents: a retrospective, comparative study from a tertiary psoriasis referral centre. J Eur Acad Dermatol Venereol. 2016;30:2091-2096.
      3. Strober B, et al. Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council. J Am Acad Dermatol. 2020;82:117-122.
      4. Mattei PL, et al. Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI): the correlation between disease severity and psychological burden in patients treated with biological therapies. J Eur Acad Dermatol Venereol. 2014;28:333-337.
      5. Daudén E, et al. Consensus document on the evaluation and treatment of moderate‐to‐severe psoriasis: Psoriasis Group of the Spanish Academy of Dermatology and Venereology. J Eur Acad Dermatol Venereol. 2016;30:1-18.
      6. Svoboda SA, et al. Treatment goals in psoriasis: which outcomes matter most? Am J Clin Dermatol. 2020;21:505-511.
      7. Khoury LR, et al. Facing the dilemma of patient‐centred psoriasis care: a qualitative study identifying patient needs in dermatological outpatient clinics. Br J Dermatol. 2017;177:436-444.
      8. Kaushik SB, et al. CME part I psoriasis: which therapy for which patient psoriasis comorbidities and preferred systemic agents. J Am Acad Dermatol. 2019;80:27-40.
      9. Barker J, et al. Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience. J Dermatolog Treat. 2019;31:794-800.
      10. Carrascosa J-M, et al. Biosimilar drugs for psoriasis: principles, present, and near future. Dermatol Ther (Heidelb). 2018;8:173-194.
      11. Schiestl M, et al. Ten years of biosimilars in Europe: development and evolution of the regulatory pathways. Drug Des Devel Ther. 2017;11:1509-1515.
      12. Puig L, et al. Biosimilars for the treatment of psoriasis. Expert Opin Biol Ther. 2019;19:993-1000.
      13. Griffiths CEM, 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;176:928-938.
      14. Food and Drug Administration (FDA). Biosimilar product information. Etanercept. Updated February 2, 25, 2022. Accessed March 11, 2022. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
      15. Hagen T. NJ court decision means 3 decades of product exclusivity for Enbrel. December 1, 2021. Accessed March 11, 2022. https://www.centerforbiosimilars.com/view/nj-court-decision-means-3-decades-of-product-exclusivity-for-enbrel
      16. Kaur P, et al. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis. 2017;76:526-533.
      17. Papp K, et al. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis. Br J Dermatol. 2017;177:1562-1574.
      18. Blauvelt A, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol. 2018;179:623-631.
      19. Hanauer S, et al. Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021;6:816-825.
      20. Food and Drug Administration (FDA). Biosimilar product information. Adalimumab. Updated February 2, 25, 2022. Accessed March 11, 2022. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
      21. Hagen T. Field of potential adalimumab biosimilar contenders continues to grow. December 2, 2021. Accessed March 11, 2022. https://www.ajmc.com/view/field-of-potential-adalimumab-biosimilar-contenders-continues-to-grow
      22. Joszt L. Yusimry, the seventh adalimumab biosimilar, gains FDA approval. December 26, 2021. Accessed March 11, 2022. https://www.ajmc.com/view/yusimry-the-seventh-adalimumab-biosimilar-gains-fda-approval
      23. Genovese MC, et al. Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis. Arthritis Res Ther. 2020;22:60.
      24. Food and Drug Administration (FDA). Biosimilar product information. Infliximab. Updated February 25, 2022. Accessed March 11, 2022. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
      25. Tesser JRP, et al. Biosimilars and the extrapolation of indications for inflammatory conditions. Biologics. 2017;11:5-11.
      26. Cohen AD, et al. Biosimilars for the treatment of patients with psoriasis: a consensus statement from the Biosimilar Working Group of the International Psoriasis Council. JAAD Int. 2020;1:224-230.
      27. Kay J. Are there benefits and risks to biosimilars from a patient perspective? Rheum Dis Clin North Am. 2019;45:465-476.
      28. Mulcahy AW, et al. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7:3.
      29. Janjigian YY, et al. Talking to patients about biosimilars. Future Oncol. 2018;14:2403-2414.
      30. Rudrapatna VA, et al. Biosimilars for the treatment of inflammatory bowel disease. Pract Gastroenterol. 2019;43:84-91.
      31. Wilson A, et al. High infliximab trough concentrations are associated with sustained histologic remission in inflammatory bowel disease: a prospective cohort study. BMC Gastroenterol. 2021;21:77.
      32. Huizinga TWJ, et al. Adalimumab biosimilars in the treatment of rheumatoid arthritis: a systematic review of the evidence for biosimilarity. Rheumatol Ther. 2021;8:41-61.
      33. Moots R, 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.
      34. Luber RP, et al. An observational study of switching infliximab biosimilar: no adverse impact on inflammatory bowel disease control or drug levels with first or second switch. Aliment Pharmacol Ther. 2021;54:678-688.
      35. Jørgenson KK, 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;389:2304-2316.
      36. Goll GL, 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;285:653-669.
      37. Park W, 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;76:346-354.
      38. Yoo DH, 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;76:355-363.
      39. Glintborg B, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis. 2017;76:1426-1431.
      40. Patel PK, et al. Biologics and biosimilars. J Dermatolog Treat. 2015;26:299-302.
      41. Colloca L, et al. The clinical implications of nocebo effects for biosimilar therapy. Front Pharmacol. 2019;10:1372.
      42. Armuzzi A, et al. Enhancing treatment success in inflammatory bowel disease: optimising the use of anti-TNF agents and utilising their biosimilars in clinical practice. Dig Liver Dis. 2020;52:1259-1265.
      43. Odinet JS, et al. The biosimilar nocebo effect? A systematic review of double-blinded versus open-label studies. J Manag Care Spec Pharm. 2018;24:952-959.
      44. Pouillon L, et al. Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients. Aliment Pharmacol Ther. 2019;49:1181-1187.
      45. Alvarez DF, et al. Interchangeability of biosimilars: what level of clinical evidence is needed to support the interchangeability designation in the United States? BioDrugs. 2020;34:723-732.
      46. Afzali A, et al. The automatic substitution of biosimilars: definitions of interchangeability are not interchangeable. Adv Ther. 2021;38:2077-2093.
      « Return to: Test Your Skill: Incorporating Biosimilars Into the Management of Patients With Immunological Conditions
      CME / ABIM MOC / CE Information

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