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#236 It’s all in the details… or is it? Biosimilars versus biologics for inflammatory conditions.


CLINICAL QUESTION
QUESTION CLINIQUE
How do biosimilar medications compare to their corresponding originator biologic medications in treating patients with conditions like rheumatoid arthritis or inflammatory bowel disease?


BOTTOM LINE
RÉSULTAT FINAL
For patients with rheumatoid arthritis, other inflammatory arthropathies, or inflammatory bowel disease, biosimilars and biologics have similar clinical outcomes and adverse events. Given the cost differences, starting patients with or switching to biosimilars should be encouraged.  



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EVIDENCE
DONNÉES PROBANTES
Focusing on double-blind, randomized, controlled trials (RCTs). No differences below were statistically significant.  Switching from originator biologic to corresponding biosimilar: 
  • Publicly-funded RCT of 482 patients with mostly inflammatory bowel disease or rheumatological conditions.1 Patients stable on biologic infliximab randomized to continue biologic infliximab or switch to biosimilar infliximab. At one year: 
    • Proportion with disease "worsening" (disease specific scales or patient/provider consensus): 
      • Overall: 30% biosimilar, 26% biologic. 
      • Individual conditions: no differences. 
    • Remission rates or quality of life: similar.  
  • RCT of 195 rheumatoid arthritis patients randomized to continue biologic or switch to biosimilar infliximab.2 At 24 weeks following switch: 
    • Proportion with ≥20% symptom improvement: 
      • 64% biosimilar, 69% biologic. 
Starting on either biosimilar or biologic:  
  • All non-inferiority/equivalence studies funded by biosimilar makers.
    •  Rheumatoid Arthritis:
      • Etanercept: 3 RCTs (1266 patients):3-5
        • Proportion with ≥20% improvement at 24 weeks: 78-93% biosimilar, 80-87% biologic etanercept. 
      • Infliximab: 4 RCTs (1875 patients):6-9 
        • Proportion with ≥20% improvement at 30 weeks:7-9 61-78% biosimilar, 59-65% biologic infliximab. 
          • At 54 weeks: 64-75% biosimilar, 49-71% biologic.7,9 
      • Rituximab10and adalimumab11-13 had similar results. 
    • Crohn's Disease:  
      • Infliximab: 1 RCT (220 patients)14randomized to start biosimilar or biologic infliximab.
        • Proportion achieving clinically relevant change in symptoms at 30 weeks: 77% biosimilar, 75% biologic. 
Similar rates of serious and overall adverse events, infusion reactions, and anti-drug antibody development.1-14    Context: 
  • Regulatory agencies require biosimilars to have no clinically meaningful differences in safety and efficacy compared to originator biologic.15 
  • Canada spends annually: 
    • >$1 billion on biologics for rheumatological/gastrointestinal conditions.16
  • In Alberta:  
    • Biosimilar infliximab costs around half of biologic infliximab: 
      • 400mg dose: $2200 versus $4000.17 
  • 98% of infliximab spending is on biologic product.18
  • Some countries have substitution policies to increase biosimilar use.15 


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Author(s)
Auteur(s)
  • Danielle Perry BScN RN
  • Joey Ton BScPharm PharmD
  • Michael R Kolber MD CCFP MSc

1. Jørgensen KK, Olsen IC, Goll GL, et al. Lancet 2017: 10; 389:2304-2316.

2. Smolen JS, Choe JY, Prodanovic N, et al. Ann Rheum Dis. 2018; 77(2):234-240.

3. Emery P, Vencovsky J, Sylwestrzak A, et al. Ann Rheum Dis. 2017;76(1):51-57.

4. Matucci-Cerinic M, Allanore Y, Kavanaugh A, et al. RMD Open. 2018 Nov;4(2):e000757.

5. Bae SC, Kim J, Choe JY, et al. Ann Rheum Dis. 2017;76(1):65-71.

6. Smolen JS, Choe JY, Prodanovic N, et al. Rheumatology (Oxford). 2017;56(10):1771-1779.

7. Yoo DH, Hrycaj P, Miranda P, et al. Ann Rheum Dis. 2013;72(10):1613-20.

8. Choe JY, Prodanovic N, Niebrzydowski J, et al. Ann Rheum Dis. 2017;76(1):58-64.

9. Takeuchi T, Yamanaka H, Tanaka Y, et al. Mod Rheumatol. 2015;25(6):817-24.

10. Smolen JS, Cohen SB, Tony HP, et al. Ann Rheum Dis. 2017;76(9):1598-1602.

11. Jamshidi A, Gharibdoost F, Vojdanian M, et al. Arthritis Res Ther. 2017;19(1):168.

12. Cohen S, Genovese MC, Choy E, et al. Ann Rheum Dis. 2017;76(10):1679-1687.

13. Jani RH, Gupta R, Bhatia G, et al. Int J Rheum Dis. 2016;19(11):1157-1168.

14. Ye BD, Pesegova M, Alexeeva O, et al. Lancet. 2019; 393: 1699–707.

15. International policies on the appropriate use of biosimilar drugs. Ottawa: CADTH; 2018. (Environmental scan; no. 80).

16. CIHI: Canadian Institute for Health Information. Prescribed Drug Spending in Canada, 2018: A Focus on Public Drug Programs. Ottawa, ON: CIHI; 2018. Available at: https://www.cihi.ca/en/health-spending/2018/prescribed-drug-spending-in-canada Accessed Mar 25, 2019.

17. Biosimilar Infliximab cost: Author's calculations using data from Alberta Health Interactive Drug Benefit List. Available at: https://idbl.ab.bluecross.ca/idbl/load.do Accessed Mar 23, 2019.

18. Utilization information for Government of Alberta Sponsored Drug Programs, extracted by Alberta Blue Cross March 2019, provided by Alberta Health.

Authors do not have any conflicts of interest to declare.

Les auteurs n’ont aucun conflit d’intérêts à déclarer.