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Professional associations publish guidance advising gastroenterologists on prescribing biosimilars; however, guidelines differ between countries and change over time. This study aimed to map the presence and content of guidance from European gastroenterology associations on TNFα inhibitor biosimilar use and its development over time. Guidelines on biosimilar prescribing from national gastroenterology associations in the European Economic Area (EEA) partnered with the European Crohn’s and Colitis Organization (ECCO) were collected. Treatment guidelines and biosimilar position papers from 2010 to 2022 were included. Data were extracted using a template. 26 of 30 EEA countries have an ECCO-partnered gastroenterology association, of which 14 (53.8%) had national guidelines addressing biosimilars, four (15.4%) followed ECCO’s position, and three (11.6%) had treatment guidelines without mentioning biosimilars. From five countries (19.2%) no guidelines were retrieved. Among 18 countries with guidance, 14 (77.8%) associations endorsed initiating biological treatment with biosimilars, and 13 (72.2%) endorsed transitioning from originator to biosimilar. Nine associations published multiple guidelines over time addressing biosimilars; overall, their positions became more encouraging. The majority of gastroenterology associations endorsed biosimilar use. The lack of (up-to-date) guidelines for some associations indicates an area of improvement to support biosimilar use in clinical practice.

We will be conducting a grey literature review which aims to investigate the variations in definitions of rare diseases applied in healthcare policy. Besides the grey literature search for definitions, we will be conducting a rapid literature review which aims to identify the unmet patient and societal needs in rare diseases, including the methodological issues related to research on rare health conditions that could impact the identification of patient and societal needs in the area of rare diseases, as well as identifying examples of studies measuring unmet medical needs in rare diseases.

Additional file 3: Supplementary Box 1 Key terminology.

Additional file 2: Table S1. Community pharmacists: participants’ experience with biologicals in general. Table S2. Community pharmacists: participants’ experience with biosimilars. Table S3. Statistical analysis—testing for differences between experienced and more recently graduated pharmacists in terms of knowledge about biosimilars. Table S4. Statistical analysis—testing for differences between the self-assessed competences of pharmacists in dispensing biologicals in general versus biosimilars in particular. Table S5. Statistical analysis—testing for differences between the self-assessed competences in dispensing biologicals in general between experienced and more recently graduated pharmacists. Table S6. Statistical analysis—testing for differences between the self-assessed competences in dispensing biosimilars between experienced and more recently graduated pharmacists. Table S7. Physicians: participants’ experience with biologicals in general. Table S8. Physicians: participants’ experience with biosimilars.

Additional file 1: Figure S1. Familiarity with and knowledge about biosimilars among community pharmacists and physicians. Figure S2. Additional question on the self-assessed competence of community pharmacists to dispense biologicals (in general) and biosimilars (in particular). Figure S3. Opinion of community pharmacists about the organisation of a counselling treatment conversation for patient biosimilar use. Figure S4. Additional questions posed to community pharmacists and physicians regarding interchangeability. Figure S5. Additional questions posed to community pharmacists and physicians regarding substitution. Figure S6. Additional questions posed to community pharmacists and physicians regarding information and training needs. Figure S7. Reasons why physicians would not prescribe a biosimilar. Figure S8. Questions about the need for incentives to stimulate biosimilar prescription in the ambulatory setting.

ispartof: Belgian Journal of Medical Oncology vol:14 issue:6 pages:286-292 status: published

p.1-119; P1-64; P1-4 ill., Part 1 – Legal study 1 INTRODUCTION 9 -- 2 THE PHARMACEUTICAL SECTOR: TRENDS, PRACTICES AND CHARACTERISTICS OF THE LEGAL AND GOVERNANCE FRAMEWORK 12 -- 2.1 INTRODUCTION .12 -- 2.2 KEY STAKEHOLDERS & INNOVATION TRENDS IN THE PHARMACEUTICAL SECTOR 12 -- 2.3 CHARACTERISTICS RELEVANT LEGAL FRAMEWORK PHARMACEUTICAL SECTOR 14 -- 2.4 COSTS OF R&D, BUSINESS AND IP STRATEGIES .15 -- 3 KEY PATENT LAW PRINCIPLES AND THE PHARMACEUTICAL SECTOR .19 -- 3.1 INTRODUCTION .19 -- 3.2 THE NATURE OF PATENT RIGHTS AND THE PATENT RATIONALE 19 -- 3.3 PATENT APPLICATION PROCEDURES 21 -- 3.4 KEY PATENTABILITY CRITERIA AND PATENTING PRACTICES IN THE PHARMACEUTICAL SECTOR 23 -- 3.5 EXCEPTIONS TO PATENT RIGHTS RELEVANT FOR THE PHARMACEUTICAL SECTOR 28 -- 3.6 INTERIM CONCLUSION .31 -- 4 LEGAL AND GOVERNANCE FRAMEWORK FOR REGULATORY EXCLUSIVITIES AND TRANSPARENCY OF CLINICAL TRIALS DATA 33 -- 4.1 INTRODUCTION .33 -- 4.2 THE INTERNATIONAL AND EUROPEAN LEGAL AND GOVERNANCE FRAMEWORK RELATED TO REGULATORY EXCLUSIVITIES 34 -- 4.2.1 The International Legal Framework for Regulatory Exclusivities: TRIPs Agreement 34 -- 4.2.2 The European Legal Framework for Regulatory Exclusivities 34 -- 4.2.3 Trends, Business and Legal Practices regarding Regulatory Exclusivities 40 -- 4.3 LEGAL AND GOVERNANCE FRAMEWORK RELATED TO CTD TRANSPARENCY 43 -- 4.3.1 Introduction .43 -- 4.3.2 European Legal Framework for Clinical Trial Data Transparency 44 -- 4.3.3 Trends, Business and Legal Practices regarding Clinical Trials Transparency 45 -- 4.4 INTERIM CONCLUSION .48 -- 5 COMPULSORY LICENSING 49 -- 5.1 INTRODUCTION .49 -- 5.2 THE INTERNATIONAL AND EUROPEAN LEGAL AND POLICY FRAMEWORK FOR COMPULSORY LICENSING 50 -- 5.2.1 CLs & the International Legal Framework: Paris Convention and TRIPs Agreement 50 -- 5.2.2 CLs & the European Legal and Policy Framework: The EU Biotechnology Directive and the Unitary Patent Package, the EC Action Plan and Competition Law 59 -- 5.3 THE BELGIAN LEGAL FRAMEWORK FOR CLS .71 -- 5.3.1 Current Belgian Legal Framework for CLs .71 -- 5.3.2 CLs and Import to Belgium .74 -- 5.3.3 Legislative Proposal CLs .75 -- 5.3.4 Recommendations regarding the CL Mechanism for Public Health in Belgium and the Legislative Proposal for Excessive Pricing .78 -- 5.4 CLS FOR PUBLIC HEALTH & EXCESSIVELY PRICED MEDICINES IN OTHER COUNTRIES .80 -- 5.4.1 Key CL Mechanisms 81 -- 5.5 CLS FOR PUBLIC HEALTH & EXCESSIVELY PRICED MEDICINES IN THE NETHERLANDS .85 -- 5.6 IMPLICATIONS DATA & MARKET EXCLUSIVITIES FOR COMPULSORY LICENSING 88 -- 5.7 INTERIM CONCLUSION .91 -- 6 COMPLEMENTARY MECHANISMS WITHIN AND BEYOND THE PATENT LAW CONTEXT 92 -- 6.1 CONSIDER SOCIALLY RESPONSIBLE LICENSING CONDITIONS FOR ACADEMIA 92 -- 6.2 STIMULATE VOLUNTARY LICENSING: PATENT POOLS AND CLEARINGHOUSES 93 -- 6.3 INCREASE COLLABORATION & COORDINATION WITH NATIONAL AND EUROPEAN COMPETITION AUTHORITIES IN THE PHARMACEUTICAL SECTOR AND IN PARTICULAR FOR EXCESSIVE PRICING .94 -- 6.4 INCREASE TRANSPARENCY ON DATA AND R&D COSTS 95 -- 6.5 IMPOSE CONDITIONS ON ACCESS & PRICING IN CASE OF PUBLIC FUNDING .95 -- 6.6 INCREASE COORDINATION ON PRICING & REIMBURSEMENT 95 -- 7 CONCLUSIONS 96 -- SUPPLEMENT .99 -- APPENDIX 1. COMPETITION CASES EXCESSIVE PRICING .99 -- APPENDIX 2. TABLE COMPARATIVE ANALYSIS CLS IN OTHER COUNTRIES 109 -- APPENDIX 3. INFORMATIVE CL CASES .111 -- APPENDIX 4. SUMMARY OF THE LEGAL FRAMEWORK FOR PHARMACY PREPARATIONS IN BELGIUM .112 -- APPENDIX 4.1. EUROPEAN AND BELGIAN LEGISLATION ON NON-INDUSTRIAL PREPARATIONS 113 -- APPENDIX 4.2. QUALITY RULES PREPARATIONS BY PHARMACIES IN BELGIUM 115 -- APPENDIX 4.3. DIFFERENT PRACTICES IN THE EUROPEAN UNION .116 -- APPENDIX 5. BRIEF OVERVIEW OF THE DRUGS PRICING CRITERIA IN BELGIUM 118 Part 2 – Economic study LIST OF ABBREVIATIONS 3 -- 1 PROBLEM DESCRIPTION 4 -- 2 OBJECTIVES 5 -- 3 LITERATURE REVIEW METHODS 5 -- 3.1 UNDERSTANDING THE CONSEQUENCES OF COMPULSORY LICENSING 5 -- 3.2 COMBINING THEORY WITH PRACTICE 5 -- 3.3 APPLYING A FLEXIBLE AND PURPOSIVE SEARCH STRATEGY 6 -- 3.4 EXTRACTING AND SYNTHESISING DATA 6 -- 3.5 INTERACTING WITH THE STUDY COMMISSIONER 6 -- 4 LITERATURE REVIEW RESULTS 7 -- 4.1 SEARCH FLOW DIAGRAM . 7 -- 4.2 DATA EXTRACTION 8 -- 4.2.2 Empirical studies 19 -- 4.2.3 Remuneration .31 -- 5 EXAMINING THE ECONOMIC IMPACT OF CL FOR MEDICINES 33 -- 5.1 INDUSTRIAL CONSEQUENCES 34 -- 5.1.1 Development of a domestic pharmaceutical industry 34 -- 5.1.2 Reduced investment by originator pharmaceutical companies 37 -- 5.1.3 Reduced investment from other industries vulnerable to IP protection 39 -- 5.1.4 State retaliation .39 -- 5.2 HEALTH CONSEQUENCES .40 -- 5.2.1 Increased access for patients to expensive, innovative drugs .40 -- 5.2.2 Freeing of resources that can be invested elsewhere 41 -- 5.2.3 Reduced access to innovative drugs through fewer drug launches or fewer trials 41 -- 5.2.4 Reduced supply of innovative medicines due to lower investment in R&D 41 -- 5.3 ADEQUATE REMUNERATION FOR COMPULSORY LICENSES 42 -- 5.3.1 Adequate remuneration of CL in developing economies .43 -- 5.3.2 Adequate remuneration of CL in developed economies 44 -- 6 CONCLUSION .48 -- APPENDIX 1. SEARCH STRATEGY 58 -- APPENDIX 1.1. SEARCH STRATEGY IN GENERAL 58 -- APPENDIX 1.2. SEARCH STRATEGY FOR PEER-REVIEWED LITERATURE 59 -- APPENDIX 1.3. SEARCH STRATEGY FOR GREY LITERATURE .64 Part 3 – Overall conclusions