Prof Bjorn Moum of Oslo University Hospital Ulleval, Norway provides an international perspective on biologic & biosimilar medicines.

1. Experience with biosimilars in Norway
The Oslo University Hospital Experience
Bjørn Moum
Professor
Department of
Gastroenterology
Oslo University Hospital

2. Current Resources used in IBD after 2000
Therapeutic Approach to IBD
2012 2014
18% -> 20%

3. Biologicals & Biosimilars N:
• 1st Biologicals for IBD available in 2000
• Approval 1st biosimilar 28th Feb 2014

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

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

10. Department of gastroenterology at OUS - 2014
• 14,000 outpatient contacts
• 9000 endoscopies :
• 3500 :
- Day care unit 250 inf /mths (3000/yr) - IBD
- IBD consultations ++

11. Biologicals & Biosimilars N:
«History»
Approval 1st biosimilar 28th Feb 2014
• LIS* 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

12. Biologicals & Biosimilars:
OUS (Ullevaal) Department of Gastroenterolgy
• NOR 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)

14. Biologicals & Biosimilars:
OUS (Ullevaal) Department of Gastroenterolgy
2014 IFX: 4 mill Euro year
2014 IFX: (39% discount)
2015 Sept: (79% discount & shifting!)
• Switching to biosimilar IFX= savings 1.7 mill Euro
• adalimumab 160 pts: 2.7 mill Euro
o biosimilars to adalimumab expected 2018

15. Biologicals & Biosimilars:
OUS (Ullevaal) Department of Gastroenterolgy
• Switching 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 2015/2016
– One IBD nurse employed 2015/2016

16. 0%
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90%
Remsima marketshare

17. Clinical consequences introducing biosimilars
• More 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
α4β7-integrin)
• Patients not stopping biologics on economic reasons

18. • 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

19. • Have come to stay
• Safe …. so far
• Resources saved
• More biosimilars -> compexity
• Future ……?
Conclusion - biosimilars

20. • more biosimilars expected (adalimumab in 2018)
• ‘biogenerics‘
erythropoietin obtained by complete chemical synthesis recently
• ‘biobetter’
• ‘biosuperiors’
• second generation biologics
The Future