Eisen en Verplichtingen

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1 Registratie ti van Biosimilars: i il Eisen en Verplichtingen Dr. Thijs J. Giezen Ziekenhuisapotheker, Stichting Apotheek Haarlemse Ziekenhuizen Lid, CHMP Biosimilar Working Party (BMWP), European Medicines Agency, Londen I attend this conference as an individual expert, and do not represent the CHMP/BMWP. The views expressed here are my personal views, and may not be understood d or quoted as being made on behalf of the CXMP/WP/SAG or reflecting the position of the CHMP/BMWP. 4-apr.-15 1

2 European Medicines Agency Established in 1995 by Regulation (EEC) No. 2309/93 Re-established in 2004 by Regulation (EC) No. 726/ apr.-15 2

3 4-apr.-15 3

4 Biologicals Sanquin Banting & Best Recombinant DNA technology 1900s Salvaran 1931 Sulfonamide 2000s Biosimilars 1897 Aspirin 1920s Insulin 1980s Recombinant DNA technology 4-apr.-15 4

5 Biologicals are complex Apirin MW: 0.2 kda IgG ~1300AA, MW: ~150 kda IFN alfa 165AA, MW: 19 kda 4-apr.-15 5

6 Biologicals are important treatment options Before treatment After treatment Source: EMA Homepage, European Public Assessment Report (EPAR) 4-apr.-15 6

7 But treatment costs are high Slide by Paul Cornes, MD presented at EGA Annual Conference on Biosimilars 14 April 2011 London 4-apr.-15 7

8 What is a biosimilar? Directive 2001/83/EC (as amended) Article 10: Generics Generics and legal basis for biosimilars Article 10(2a): Generic medicinal product shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, ( ). Article 10(4): Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. 4-apr.-15 8

9 The process is the product Source: Talk Inger Mollerup, Novo Nordisk A/S Joint EMEA/DIA Workshop on Biosimilars, Paris apr.-15 9

10 And processes are very different Source: Talk Inger Mollerup, Novo Nordisk A/S Joint EMEA/DIA Workshop on Biosimilars, Paris apr

11 What is a biosimilar? a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA. Similarity to the reference medicinal product in terms of quality characteristics, biological l activity, safety and efficacy based on a comprehensive comparability exercise needs to be established Guideline on Similar Biological Medicinal Products 4-apr

12 EMA Guidelines 4-apr

13 Development of a biosimilar: the process Tailoring - Analysis of multiple batches of reference product Fitting - Adjustments to production process of biosimilar Comparison - Comparison of physicochemical h i and in vitro characteristics between biosimilar and reference product Confirmation - PK/ PD and clinical efficacy and safety study 4-apr

14 Development of a biosimilar McCamish. MAbs. 2011;3(2): apr

15 Fingerprint approach From J. Goncalves; TOPRA meeting 4-apr

16 Dossier requirements for biosimilars CTD Module Originator Biosimilar 3 4 Cross reference 5 Cross reference Cross reference Integrated Comparability Exercise class specific product specific Safety and Efficacy Quality, Safety and Efficacy Falk Ehmann, European Medicines Agency 4-apr

17 Development of a biosimilar How much similarity do we need? How much do we need to know? 4-apr

18 Comparability exercise Technical term to show that two biological / biotechnological products are similar / comparable il 1) Scenario 1: After a change in the manufacturing process of a given product (pre- and post-change product from the same manufacturer) 2) Scenario 2: In a biosimilarity exercise (two products from different manufacturers) Scenario 1: Manufacturer has all the data and experience Scenario 2: Manufacturer does not have the data from the originator company 4-apr

19 Development of a biosimilar Step-wise approach is the key principle in biosimilar development Mainstay is an extensive physicochemical and biological characterisation: Form and function of the molecule - Same primary, secondary and tertiary structure - Comparable post-translational profile Pre-clinical tests - Extensive in vitro characterization of biological activity - In vivo only in case of remaining uncertainties based on physicochemical and biological characterization and in vitro studies and animal studies should add valuable information (=exceptional) 4-apr

20 Clinical efficacy The aim of a biosimilar development programme is not to establish benefit of a treatment for the patient (this had been done before for the reference product!) The aim is to establish biosimilarity! This means: - The clinical study follows the idea that patients are models - The clinical study is selected to represent the most sensitive model to study differences - Thus, trial design might be (entirely) different from the normal guideline principles! - Scientifically not abridged, but rather tailored development 4-apr

21 Clinical safety Safety profile should be comparable Immunogenicity should specifically be studied Higher immunogenicity would question biosimilarity However, lower immunogenicity i it might be acceptable 4-apr

22 Extrapolation of indication Extrapolation of indications is a key aspect in the approval of biosimilars Additional data needed if: - Different receptors in different indications - Differences in immunogenicity - Differences in co-medication - Etc. 4-apr

23 Pharmacovigilance Same rules apply to biosimilar as to all biologicals: - Biosimilar companies should submit a risk management plan - Collect spontaneously reported adverse events e - Submit Periodic Safety Update Reports Traceability is of high importance for all biologicals (this is specifically addressed in the pharmacovigilance legislation) 4-apr

24 Naming of biologicals Traceability is of high importance Adverse events should be reported based on brand name and batch number Do differences in INN between biosimilar and reference product lead to misunderstanding? Or is the same INN with a qualifier acceptable? 4-apr

25 After approval Biosimilars and reference products make their own changes to the production process Scenario 1: After a change in the manufacturing process of a given product (pre- and post-change product from the same manufacturer) 4-apr

26 Public misperception Slide courtesy of M. Weise (BfArM) 4-apr

27 Importance of terminology Non-innovator erythropoietins 4-apr

28 Importance of terminology Brockmeyer and Seidel, EJHP apr

29 4-apr

30 Public misperception 4-apr

31 Concluding remarks Differences in production process can influence characteristics of the end product A thorough physicochemical characterisation is the basis for biosimilar development Step-wise approach is highly recommended Remaining uncertainties are tackled by non-clinical and clinical studies Biosimilarity is concluded based on totality of evidence Biosimilars i il are similar il to the reference product 4-apr

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