L esperienza clinica con il biosimilare in Italia. Paolo Lionetti

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Sabina Poletti
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1 L esperienza clinica con il biosimilare in Italia Paolo Lionetti

2 EMA Recommendation for infliximab biosimilars Remsima and Inflectra are biosimilar to infliximab Same non-proprietary name Randomized controlled trials have demonstrated comparable quality, safety, and efficacy profiles to infliximab in: AS (Phase I: 250 patients) RA (Phase III: 606 patients) EMA extrapolated data to all approved Remicade indications: RA, adult and pediatric Crohn s disease, adult and pediatric ulcerative colitis, AS, psoriatic arthritis, and psoriasis A pharmacovigilance plan for Remsima will be implemented as part of the marketing authorization Same label (Summary of Product Characteristics) as Remsima and Inflectra

5 STATEMENTS EMA approved the use of biosimilars for infliximab for all indications, including adult and paediatric IBD. The committee advocates for urgent paediatric trials with long term follow-up to support this istance. 97% agreement Treatment of a child with sustained remission on a specific medication should not be switched to a biosimilar until clinical trials in IBD are available to support the safety and efficacy of such a change. 94% agreement Post-marketing surveillance programs for efficacy, safety and immunogenicity should be mandatory in children with IBD using biosimilars. 100% agreement

6 EMA approved the use of biosimilars for infliximab for all indications, including adult and paediatric IBD. The committee advocates for urgent paediatric trials with long term follow-up to support this istance. 97% agreement Treatment of a child with sustained remission on a specific medication should not be switched to a biosimilar until clinical trials in IBD are available to support the safety and efficacy of such a change. 94% agreement Post-marketing surveillance programs for efficacy, safety and immunogenicity should be mandatory in children with IBD using biosimilars. 100% agreement

7 - Estimated average cost expenditure reduction 30-35% - Cost expenditure reduction Region of Tuscany : 40%

8 La regione Toscana, con delibera n. 450 del 07/04/32015 ha invitato i medici specialisti, alla scadenza del brevetto, ad utilizzare i farmaci biologici o biosimilari aggiudicati all ESTAR nella procedura pubblica di acquisto, salvo documentate eccezioni

9 CT-P13 open label extension trials in RA and AS Open label extension, all pts receiving CT-P13 Approx. 66% entering OLE R CT-P13 Remicade Continue CT-P13 Switch to CT-P13 Double-blind Open label extension Wk 0 Wk 54 Wk 102 Posters presented as late breaking abstracts at ACR 2013

10 Percent of patients (%) Continued CT-P13 vs Switching From Remicade to CT-P13 in PLANET-RA Yoo et al. ACR 2013, L1 Wk 52 Wk 78 Wk 102

12 Il consenso informato per lo switch ORIGINATOR BIOSIMILARE

13 Il consenso informato per lo switch ORIGINATOR BIOSIMILARE

18 Switching Between Infliximab Originator and Biosimilar in Pediatric Patients with Inflammatory Bowel Disease.

20 p< p=0.16 p=0.23 p=0.10

21 CRP CD p = p = 0.13 p = 1.13 p = 0.7

23 PUCAI p<0.05 p=0.23 p=0.7 p=0.6

24 CRP UC p = 0.2 p = 0.4 p = 0.6 p = 0.4

25 FCP UC p = 0.13 p = 0.55 p = 0.88 p = 0.6

27 CONCLUSIONI Nonostante il limitato numero dei pazienti ed il relativamente breve periodo di osservazione, questi dati ci consentono di affermare che il passaggio da IFX originale al biosimilare non sembra comportare differenze in termini di efficacia, immunogenicità e sicurezza.

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