The EU Market Environment for Biosimilar Medicines

Transcription

1 1

2 The EU Market Environment for Biosimilar Medicines 12 th Annual IGPA Conference Sep 30-Oct 2, 2009 Montreal Suzette Kox Senior Director Scientific Affairs European Generic medicines Association 2

3 Outlines Definitions/terminologies in the EU context EU biosimilar market environment Regulatory framework Supply Demand EGA Vision: global development 3

4 Definitions (1) Biosimilar Medicines Within EU: Approved according to EU legislation Outside EU: approved on the basis of equivalent standards to the EU A biosimilar medicine has shown to have a comparable quality/safety/efficacy profile to the reference product and is therefore qualified for therapeutic interchangeability with the reference product 4

5 Definitions (2) Interchangeability (Ability to interchange) Refers to the medical practice of changing one medicine for another that is equivalent in a given clinical setting on the initiative or with the agreement of the prescriber 5

6 Definitions (3) Substitutability (Ability to substitute) Refers to the practice of dispensing one medicine instead of another equivalent medicine at the pharmacy level without requiring consultation with the prescriber Substitution is either allowed, required or excluded according to national or local rules 6

7 Definitions (4) Automatic Substitution Refers to the practice whereby a pharmacist is obliged to dispense one medicine instead of another equivalent medicine due to national or local requirements 7

8 Understand the Market Environment for Biosimilar Medicines... Demand Biosimilar Market Supply Regulatory environ ment 8

9 Understand the Market Environment for Biosimilar Medicines... Demand Supply Bio similar Market Regulatory environment 9

10 Consolidation of EU Biosimilar Thinking Further consolidation in 2008/9 EU continues to lead worldwide in developing guidelines and inspiring ROW New mile stone in 2009: EMEA Biosimilar Monoclonal Antibodies (mabs) workshop (2 July 2009) mabs: key for patient access and the sustainability of the biosimilar medicines industry 10

11 Safe and Secured Environment Company must have a risk-management system in place before approval ie a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks European Commission new pharmacovigilance legislative proposal 11

12 G.Lalis/Director General EC on Pharmacovigilance for Biosimilars EGA Annual Conference Paris 6/08 12

13 Reported ADRs Assigned to the Right Product EU legal obligation: An adverse reaction report for any biological drug should always include full name of the biological drug batch number Where information is missing, Member States/MAHs should ensure that reports are followed up for completion 13

14 Impact on Prescribing and National Substitution Policies Biosimilar medicines are prescribed by brand names (INN-MAH/trademark or invented name) Interchangeability takes place eg. all biologicals excluded from substitution in Spain; no biosimilar substitution list in France No automatic substitution for biologicals in the EU 14

15 Understand the Market Environment for Biosimilar Medicines... Demand Bio similar Market Supply Regulatory environ ment 15

16 Our Industry is Delivering 13 Products (6 developments) Somatropin(2) Epoetin(5) Filgrastim (6) Withdrawl/rejection Interferon alfa (1) Insulin (3) 16

17 Number bios imilar applic ations for initial evaluation Positive Trend of Biosimilar Applications Continues Year Source: EGA graph based on figures published in the EMEA Annual Work Programmes 17

18 Number of applications Increase of Scientific Advice Biosimilar Scientific Advice (Mar 2009) Follow up advice First advice Year Source/EMEA presentation slide/ T. Lönngren/ EGA symposium on biosimilar medicines 18 18

19 Understand the Market Environment for Biosimilar Medicines... Demand Bio similar Market Supply Regulatory environ ment 19

20 Positive Developments in the Market Place EU clinical experience of biosimilar products continues to grow Market inroads are made Biosimilar medicines industry very confident about the future 20

21 Denigration of Biosimilar Products Highlighted by the Mutualité Française In the context of its sector inquiry, the French Mutuality asks the European Commission to mention the denigration campaigns put in place by originator companies with the aim of maintaining an aura of suspicion around biosimilars. Indeed originator companies spread alarmist and often worrisome news regarding the difficulty of reproducing biotechnology derived products. (Public submission sector inquiry-ega internal translation) 21

22 Building Trust: Industry- Regulator Cooperation Challenging misinformation, misinterpretation, misperceptions = shared responsibility by industry and regulators for the sake of patients 22

23 EGA Vision to Increase Access to High Quality Affordable Biotech Medicines 23

24 EU Inspiring the Rest of the World Towards Harmonisation of Requirements Canada EU legal framework firmly established JP Final guideline released on March 4, 2009 Japan USA Legislation expected soon Venezuela Turkey Saudi-Arabia India Taiwan Malaysia Mexico Argentinia Columbia Brazil WHO draft guidance to be finalised end 09 Australia EU guidelines adopted 24 Source: Sandoz

25 Global Development Based on a Stepwise Approach to Demonstrating Comparability of Reference Products and Biosimilar JP US EU Requirements rigorous physicochemical and biological comparison with reference product of different regions appropriate comparative pre-clinical testing with reference product of different regions in case of physico-chemical differences shown between drugs rigorous comparative PK/PD clinical phase I studies with reference product of different regions Source: Sandoz comparative clinical phase III studies with reference product from one region only (against either EU reference product or US reference product) 25

26 Global Development for Biosimilar Medicines Streamlining the development process Avoids repetition of unnecessary trials Increases competition which will stimulate the discovery of new live saving medicines Is a must to remain competitive and financially viable Is crucial to ensure worldwide availability, affordability and patient access to biotech medicines 26

27 Thank you very much 27

28 Acronyms EGA European Generic medicines Association EU European Union WHO World Health Organization ROW Rest of World MAA Marketing Authorisation Application MAH Marketing Authorisation Holder INN International Non-Proprietary Name ADR Adverse Drug Reaction RMP Risk Management Plan 28