Biosimilars Demystified

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1 Biosimilars Demystified Thijs J. Giezen, PhD, PharmD, MSc Hospital Pharmacist, Foundation Pharmacy for Hospitals in Haarlem Member Biosimilar Working Party, European Medicines Agency 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 or quoted as being made on behalf of the CXMP/WP/SAG or BIOSIMILARS reflecting the position of the CHMP/BMWP. 1

2 Biologicals Sanquin Banting & Best Recombinant DNA technology 1900s Salvaran 1931 Sulfonamide 2000s Biosimilars 1897 Aspirin 1920s Insulin 1980s Recombinant DNA technology 2

3 But treatment costs are high Slide by Paul Cornes, MD presented at EGA Annual Conference on Biosimilars 14 April 2011 London 5

4 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 activity, safety and efficacy based on a comprehensive comparability exercise needs to be established Guideline on Similar Biological Medicinal Products (www.ema.europa.eu) 9

5 The process is the product Source: Talk Inger Mollerup, Novo Nordisk A/S Joint EMA/DIA Workshop on Biosimilars, Paris apr.-15 7

6 And processes are very different Source: Talk Inger Mollerup, Novo Nordisk A/S Joint EMA/DIA Workshop on Biosimilars, Paris apr.-15 8

7 EMA Guidelines 10

8 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 and in vitro characteristics between biosimilar and reference product Confirmation - PK/ PD and clinical efficacy and safety study 11

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

10 Dossier requirements for biosimilars CTD Module Originator Biosimilar 3 4 Cross reference 5 Cross reference Cross reference class specific Safety and Efficacy Integrated Comparability Exercise product specific Quality, Safety and Efficacy Falk Ehmann, European Medicines Agency 14

11 Development of a biosimilar How much similarity do we need? How much do we need to know? 15

12 Comparability exercise Technical term to show that two biological / biotechnological products are similar / comparable 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 16

13 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) 17

14 Clinical efficacy and safety The aim of a biosimilar development program 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 Immunogenicity is an important part of biosimilar development 18

15 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. 20

16 Pharmacovigilance Same rules apply to biosimilar as to all biologicals: - Biosimilar companies should submit a risk management plan - Collect spontaneously reported adverse events - Submit Periodic Safety Update Reports Traceability is of high importance for all biologicals 21

17 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) 23

18 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 should be applied Biosimilarity is concluded based on totality of evidence Biosimilars are similar to the reference product 29

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