PowerPoint Presentation

Experience with biosimilars in Norway

The Oslo University Hospital Experience

Bjrn MoumProfessorDepartment of GastroenterologyOslo University Hospital

Current Resources used in IBD after 2000Therapeutic Approach to IBD

2012201418% -> 20%

Biologicals & Biosimilars N: 1st Biologicals for IBD available in 2000

Approval 1st biosimilar 28th Feb 2014

Tidsskir Nor Legeforen nr, 8, 2014: 134:819-20

Tidsskir Nor Legeforen nr, 8, 2014: 134:819-20

Department of gastroenterology at OUS - 201414,000 outpatient contacts9000 endoscopies : 3500 :- Day care unit 250 inf /mths (3000/yr) - IBD - IBD consultations ++

Biologicals & Biosimilars N: HistoryApproval 1st biosimilar 28th Feb 2014LIS* price NOK 89.000 (Remsima): 39% reduction to originator infliximab (Remicade)

LIS price 26th Feb 2015 NOK 43 000 (79% reduction)

LIS price 28th Feb 2016 NOK 62 000 (+40% increase Remsima)NOK 50 000 (- 20% reduction Inflectra)

* LIS - Drug procurement cooperation

Biologicals & Biosimilars: OUS (Ullevaal) Department of GastroenterolgyNOR Switch started May 2014

All new IBD patients Remsima -

All IBD patients switched from Remicade to Remsima Sept 2015

Switching om medical reasons - Remsima (Stable adalimumab patients continue adalimumab)

Biologicals & Biosimilars: OUS (Ullevaal) Department of Gastroenterolgy

2014 IFX:4 mill Euro year2014 IFX:(39% discount)2015 Sept:(79% discount & shifting!)

Switching to biosimilar IFX= savings 1.7 mill Euro

adalimumab 160 pts: 2.7 mill Eurobiosimilars to adalimumab expected 2018

Biologicals & Biosimilars: OUS (Ullevaal) Department of GastroenterolgySwitching to biosimilar = savings: 1.7 mill Euro

Negotiated gain share to improve IBD service and improve patient care/quality assure Aug 2015:One extra clinician employed 2015/2016One IBD nurse employed 2015/2016

Clinical consequences introducing biosimilarsMore patients introduced to biologicals; moderate disease. Patients introduced to biologicals earlier (even before steroids; change the disease course; prevent complications) Patients will have intensified dosage (high inflammatory burden, overcome neutralizing antibody formation -> preventing loss off response)Patients on biological combination treatment (TNFalfa and 47integrin)Patients not stopping biologics on economic reasons

If switching to the cheaper biosimilar leads to more patients on biologics, who will end up with these costs? Not only the pure costs of medicine, but also need for equipment, rooms, medical staff Will the reduced price by originator to match biosimilar, put the biosimilar out of business? Will reduced price affect funding for innovative therapy from big pharma?

Future Questions

Have come to stay Safe . so far Resources savedMore biosimilars -> compexity Future ?Conclusion - biosimilars

more biosimilars expected (adalimumab in 2018) biogenericserythropoietin obtained by complete chemical synthesis recently biobetterbiosuperiorssecond generation biologicsThe Future