5 key characteristics

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1 Biosimilars 5 key characteristics Biologics are medicinal products derived from living organisms. 1 Their use has impacted the treatment of a variety of diseases. 1 Patents for many biologics will soon expire, and there is an opportunity for the emergence of biosimilars. 2 A biosimilar is a biologic that is developed to be highly similar to the reference biologic, with no clinically meaningful differences in terms of quality, safety and efficacy How does a biologic differ from a small molecule drug? Small Molecule Drugs Biologics atoms 4 Small molecule drugs are produced by chemical synthesis and have well-defined structures and lower molecular weights ,000 atoms 4 Biological products are produced using living cells and have complex, heterogeneous structures and high molecular weights 4 Chemical synthesis 4,5 Biologically produced 4,5

2 Chemical synthesis 4,5 Biologically produced 4,5 Chemical drugs are more stable to their environment 4,6 Biological drugs are sensitive to changes in physical conditions 4,6 Various administration routes including oral 4 and topical 7 Parenteral administration 4 Mostly non-immunogenic 4 Potentially immunogenic 4 What are biosimilars? 02 Reference Product Biosimilar The active substance of a biosimilar and its reference medicine is essentially the same biological substance, though there may be minor differences due to their complex nature and production methods. Like the reference medicine, the biosimilar has a degree of natural variability. When approved, its variability and any differences between it and its reference medicine will have been shown not to affect safety and effectiveness What is the potential of biosimilars? Biosimilars may: 2

3 03 What is the potential of biosimilars? Biosimilars may: 2 Provide potential savings and efficiencies to the healthcare system Be a lower cost alternative to off-patent biologic therapies Increase access to biologic therapies How are biosimilars developed?04 The goal of biosimilar development is to demonstrate no clinically meaningful differences between the biosimilar and its reference product. 3 Differences between the two molecules are detected through extensive molecular characterisation and non-clinical comparison. Upon establishing that there are no significant differences between the molecules, the clinical studies are performed to confirm that the drug s safety and efficacy in patients is as expected. 8 Novel Biologics Foundation of Safety and Efficacy 9 Less Analytical Non-clinical Clinical Pharmacology Pharmacokinetics (PK) / Pharmacodynamics (PD) More Clinical ISK

4 More Clinical Biosimilars Similarity Is Priority DETERMINATION OF FAVOURABLE THERAPEUTIC BENEFIT:RISK More Analytical Comparative Non-clinical Comparative Clinical Pharmacology PK / PD Comparative Clinical Less The core development programme for biosimilars typically include: 9 Comparative non-clinical assessment Comparative clinical pharmacokinetics and pharmacodynamics studies Comparative clinical studies

5 typically include: 9 Comparative non-clinical assessment Comparative clinical pharmacokinetics and pharmacodynamics studies Comparative clinical studies The reference medicinal product may have more than one therapeutic indication: Once biosimilarity has been demonstrated, extrapolation to indications not investigated in the clinical studies, is not a given. If the mechanism of action is the same, the indication can be extrapolated. However if the mechanism is different or unknown, additional comparative data to the originator such as pharmacodynamics or functional assays are required. This data is then weighed up as part of the totality of the evidence 8 It is expected that the safety and efficacy can be extrapolated when biosimilar comparability has been demonstrated by thorough physico-chemical and structural analyses as well as by in vitro functional tests complemented with clinical data (efficacy and safety and/or PK/PD data) in one therapeutic indication 9 05 What are some myths and facts about biosimilars? MYTHS FACTS Biosimilars are generics Biosimilars are not generics. Unlike generics, the active ingredients in biosimilars are not identical to the reference product 3 Biosimilars are intended copies or me-too biologics Intended copies or Non-comparables are not the same thing as biosimilars. Unlike biosimilars, these biologics may not have been approved via a robust biosimilar regulatory pathway 1 The safety and efficacy Biosimilars are biological medicines

6 and efficacy of biosimilars are not established at time of approval biological medicines that have been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy 3 Biosimilars have not yet been approved There are approved biosimilars in various countries. Europe approved the first biosimilar in Biologics have contributed significantly to patient care and have benefited millions of patients. As the patents for biologics expire, biosimilars offer an opportunity to decrease cost and improve patient access, which may lead to better overall health outcomes, and provide savings and efficiencies to the healthcare system. 2 The objective of biosimilar development is for the biologic to be shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy. 3 References 1. Mysler, E. et al Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology, Rheumatol Int 2016; 36: Henry D, Taylor C. Pharmacoeconomics of cancer therapies: considerations with the introduction of biosimilars. Semin Oncol. 2014;41(suppl 3):S13-S20 3. NHS (2015) What is a Biosimilar Medicine? NHS website, Available at Last accessed October Mishra, N., Yadav, S., Biosimilars or follow on biologics a Revolutionary Change in Biotechnology. International Journal of Therapeutic Applications, 2012; 4: Sitte, H., Freissmuth, M., Biosimilars versus generics: scientific basics and clinical implications, memo 2013;6: Mora, F. Biosimilar: what it is not, Br J Clin Pharmacol, 80(5): Strober BE, Armour K, Romiti R, et al. Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know. J Am Acad Dermatol. 2012;66(2): Weise, M., et al, Biosimilars: what clinicians should know. Blood, 2012; 26(120): EMA (2014) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, EMA website, Available at library/scientific_guideline/2015/01/wc pdf Last accessed October EMA (2013) European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars, EMA website, Available at eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news _detail_ jsp&mid=wc0b01ac058004d5c1 Last accessed October 2016 This material has been developed by Pfizer Ltd. PP-GEP-GBR-0233 Date of preparation: October 2016