15,832
Views
9
CrossRef citations to date
0
Altmetric
Short Communication

Real-World Use and Acceptance of Rituximab Biosimilars in Non-Hodgkin Lymphoma in an Oncologist Network in Germany

, , , &
Pages 1001-1012 | Received 02 Mar 2020, Accepted 25 Mar 2020, Published online: 14 Apr 2020

References

  • Grillo-Lopez AJ , WhiteCA, DallaireBKet al. Rituximab: the first monoclonal antibody approved for the treatment of lymphoma. Curr. Pharm. Biotechnol.1(1), 1–9 (2000).
  • ESMO Guidelines Committee . Appendix 4: Chronic lymphocytic leukaemia: eUpdate published online 27 June 2017 (www.esmo.org/Guidelines/Haematological-Malignancies). Ann.Oncol.28(Suppl. 4), iv149–iv152 (2017).
  • EMA . Assessment report: Rixathon (2017). www.ema.europa.eu/en/documents/assessment-report/rixathon-epar-public-assessment-report_en.pdf
  • EMA . Truxima EPAR (2016).
  • Jaeger U . Rituximab biosimilars open new horizons in immunotherapy. ESMO Open2(3), e000234 (2017).
  • Jurczak W , DlugoszDanecka M, BuskeC. Rituximab biosimilars for lymphoma in Europe. Expert Opin. Biol. Ther.19(10), 1045–1056 (2019).
  • Visser J , FeuersteinI, StanglerT, SchmiedererT, FritschC, SchiestlM. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. BioDrugs27(5), 495–507 (2013).
  • da Silva A , KronthalerU, KoppenburgVet al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk. Lymphoma55(7), 1609–1617 (2014).
  • Jurczak W , MoreiraI, KanakasettyGBet al. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet. Haematol.4(8), e350–e361 (2017).
  • Smolen JS , ChoeJY, ProdanovicNet 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.77(2), 234–240 (2018).
  • Tony HP , KrugerK, CohenSBet al. Brief report: safety and immunogenicity of rituximab biosimilar gp 2013 after switch from reference rituximab in patients with active rheumatoid arthritis. Arthritis Care Res. (Hoboken)71(1), 88–94 (2019).
  • Kim WS , BuskeC, OguraMet al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol.4(8), e362–e373 (2017).
  • Ogura M , SanchoJM, ChoSGet al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol.5(11), e543–e553 (2018).
  • Yoo DH , SuhCH, ShimSCet al. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann. Rheum. Dis.76(3), 566–570 (2017).
  • Yoo DH , SuhCH, ShimSCet al. Efficacy, safety and pharmacokinetics of up to two courses of the rituximab biosimilar CT-P10 versus innovator rituximab in patients with rheumatoid arthritis: results up to week 72 of a Phase I randomized controlled trial. BioDrugs31(4), 357–367 (2017).
  • Park W , Bozic-MajstorovicL, MilakovicDet al. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. MAbs10(6), 934–943 (2018).
  • Park W , SuhCH, ShimSCet al. Efficacy and safety of switching from innovator rituximab to biosimilar CT-P10 compared with continued treatment with CT-P10: Results of a 56-week open-label study in patients with rheumatoid arthritis. BioDrugs31(4), 369–377 (2017).
  • Smolen JS , CohenSB, TonyHPet al. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann. Rheum. Dis.76(9), 1598–1602 (2017).
  • Jurczak W , CohenS, IllidgeTM, SilvaAD, AmersdorfferJ. Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases. Future Oncol.15(36), 4223–4234 (2019).
  • McCamish M , WoollettG. Worldwide experience with biosimilar development. MAbs3(2), 209–217 (2011).
  • Rugo HS , LintonKM, CerviP, RosenbergJA, JacobsI. A clinician’s guide to biosimilars in oncology. Cancer Treat Rev.46, 73–79 (2016).
  • Weise M , BielskyMC, DeSmet Ket al. Biosimilars: what clinicians should know. Blood120(26), 5111–5117 (2012).
  • Bennett CL , ChenB, HermansonTet al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol.15(13), e594–e605 (2014).
  • Weise M , KurkiP, Wolff-HolzE, BielskyMC, SchneiderCK. Biosimilars: the science of extrapolation. Blood124(22), 3191–3196 (2014).
  • Krause A , AriesPM, BergerSet al. Rituximab in routine care of severe active rheumatoid arthritis: a prospective, non-interventional study in Germany. Z Rheumatol.78(9), 881–888 (2019).
  • Horvat M , ZadnikV, JuznicSetina Tet al. Diffuse large B-cell lymphoma: 10 years’ real-world clinical experience with rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisolone. Oncol. Lett.15(3), 3602–3609 (2018).
  • Reiser M , DorfelS, HenselMet al. Rituximab in combination with chemotherapy for the treatment of chronic lymphocytic leukaemia in clinical practice. Eur. J. Haematol.100(5), 455–464 (2018).
  • Chaoui D , ChoquetS, SanhesLet al. Relapsed chronic lymphocytic leukemia retreated with rituximab: interim results of the PERLE study. Leuk. Lymphoma58(6), 1366–1375 (2017).
  • Wendler J , BurmesterGR, SorensenHet al. Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective, multicentre, non-interventional study in 2,484 patients. Arthritis Res. Ther.16(2), R80 (2014).
  • Cziraky M , PollockM. Real-world evidence studies (2015). www.appliedclinicaltrialsonline.com/real-world-evidence-studies
  • Christel M . “Evidence” trail elusive (2014) www.appliedclinicaltrialsonline.com/evidence-trail-elusive-0
  • Franceschetti A , BaskettA, BayntonE, BaldockD, KarkiC. Comparative analysis of biosimilar rituximab usage in treating non-Hodgkin lymphoma and rheumatoid arthritis: results from a multi-country study in Europe. Presented at ISPOR EU, Barcelona, Spain (2018). https://tools.ispor.org/research_pdfs/60/pdffiles/PHP113.pdf
  • Wiland P , BatkoB, BrzoskoMet al. Biosimilar switching - current state of knowledge. Reumatologia56(4), 234–242 (2018).
  • EMA . Biosimilars in the EU (2019) www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf
  • Cohen HP , BlauveltA, RifkinRM, DaneseS, GokhaleSB, WoollettG. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs78(4), 463–478 (2018).
  • Wilking N , LopezG, MeierK, SimoensS, van HartenW, VultoA. Can we continue to afford access to cancer treatment?Eur. Oncol. Haematol.13(2), 114–119 (2017).
  • Simoens S , van HartenW, LopezG, VultoA, MeierK, WilkingN. What happens when the cost of cancer care becomes unsustainable?Eur. Oncol. Haematol.13(2), 108–113 (2017).
  • Lopez G , VultoA, WilkingN, van HartenW, MeierK, SimoensS. Potential solutions for sustaining the costs of cancer drugs. Eur. Oncol. Haematol.13(2), 102–107 (2017).
  • McBride A , BaluS, CampbellK, MacDonaldK, AbrahamI. Subcutaneous versus intravenous rituximab in non-hodgkin lymphoma treated with R-CHOP: economic modeling for the US (ASH 2018 abstract). Blood132, 4776 (2018).
  • Giuliani J , BonettiA. The economic impact of biosimilars in oncology and hematology: the case of trastuzumab and rituximab. Anticancer Res.39(7), 3971–3973 (2019).