KCR presentation on the CEE region as a supportive place for biosimilar research, however an effort is required to bring all stakeholders to the parallel level of awareness in this area.

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3. Basic definitions
Biosimilar evolution in the EU
Biosimilar path
CRO exposure to biosimilar development – case study
Cross functional execution experience – biosimilars
CE bioequivalent studies – regional considerations
Conclusions

4. Term Definition
Biosimilar
Biological medicinal product containing a version
of the active substance of an already authorised original
biological medicinal product
Biosimilar pathway Specific provisions of EU legislation which include defined
high standards of quality, safety and efficacy
Reference medicinal
product
Another biological medicine that has already been
authorised for use applied for the comparability exercise

5. Source: Peter Richardson, Head of Quality, Specialised Scientific Disciplines Department,
European Medicines Agency

6. Source: EURODIA, Vienna Meeting, 2014

7. Source: Peter Richardson, Head of Quality, Specialised Scientific Disciplines Department,
European Medicines Agency

8. RFP date Type of drug Type of company
2010 filgrastim Generic
2010 antiCD20 Generic
2010 insulin Biotech
2011 antiCD20 Generic
2011 antiCD20 Generic
2012 antiCD20 Biotech
2012 pegfilgrastim Generics, US
2013 trastuzumab Generics, US
2013 ranibizumab Biotech, US
RFP date Type of drug Type of company
2010 filgrastim Generic
2010 antiCD20 Generic
2010 insulin Biotech
2011 antiCD20 Generic
2011 antiCD20 Generic
2012 antiCD20 Biotech
2012 pegfilgrastim Generics, US
2013 trastuzumab Generics, US
2013 ranibizumab Biotech, US

9. 0
1
2
3
2010 2011 2012 2013
Source: KCR’s CRM database (Salesforce.com), number of requests for proposal (RfP) concerning
biosimilars
#ofRfPs

10. 0
1
2
3
4
5
6
Biotech Generic
Source: KCR’s CRM database (Salesforce.com), origin of requests for proposal (RfP) concerning
biosimilars
#ofRfPs

11. Local agencies/study authorization
• Different level of recognition of biosimilar
concept
Healthcare professionals
• Gradually increasing value recognition
Patients
• Open for change

12. Bioequivalence to be proved based on non-PK data
Clinical endpoints often patient-reported
Placebo control as one of reference arms
Low treatment effect resulting in significant number of
subjects per group
Lack of ‚prejudice’ at drug agencies

13. •Ability to realize full
program within
single region
• Mastering CRO
capability
•Access to non-
reimbursed drugs
under clinical trial
•Ability to join
clinical research at
relatively low
complexity
•Lack of study type
recognition
•Decreasing role of
India
Regulatory
landscape
Physicians
perspective
CEE
benefits
Patients
perspective

14. CEE region is and will remain supportive for biosimilar
research, however an effort is required to bring all
stakeholders to the parallel level of awareness
Biosimilars are still a challenge for the industry and part
of development programs will not pursue
CE bioequivalence studies will challenge the standard
classification of research phases

15. Contact:
Anna Baran MD, Chief Medical Officer KCR S.A.
Email: Anna.Baran@kcrcro.com