Strategy for the pharmaceutical industry and biosimilars Salvatore D'Acunto European Commission Enterprise and Industry Directorate-General London, 3 April 2014 EU health policy DG Research R&D, innovation DG Internal Market Services, supply chain DG Health & Consumers Pharmaceutical Regulation DG Enterprise & Industry Competitiveness, free movement, pricing and reimbursement DG Competition Mergers and acquisitions, anti-trust DG Information Society E-health 2 1
DG ENTR activities related to pharmaceuticals Legislative initiative: revision of the "Transparency Directive" (89/105) Non-legislative initiative: Corporate Responsibility in the Pharma Sector 2010-13 Objective: to enhance collaboration to find common non-regulatory approaches for more timely and equitable access to medicines after the Marketing Authorisation Focus: Platform on Ethics & Transparency in the pharma sector Platform on Access to Medicines in Developing Countries (Africa) Platform on Access to Medicines in Europe (6 WG: Prioritisation/WHO, MEA/IT, Small Markets/SI, OTC/UK, Orphan Drugs/BE, Biosimilars/DK) 3 Project Group Biosimilars Objective: Definition of the necessary conditions for an informed uptake and an adequate patient access to biosimilar medicinal products. Final deliverables: Overview of information on reimbursement status of biosimilar medicinal products in EEA countries. IMS study on "Biosimilar accessible market: Size and biosimilar penetration. A consensus information document "What you need to know about Biosimilar Medicinal Products", with a specific Q&A for patients, physicians and payers. 4 2
"What you need to know about Biosimilar Medicinal Products" - Consensus Information Paper Objectives: Through a multi-stakeholder consensus information paper, to inform patients, physicians and payers about biosimilars as a high-quality treatment option to make healthcare professionals and national Competent Authorities fully aware of the potential of biosimilars to better realize the possible economic gains as a consequence of increased use. 5 "What you need to know about Biosimilar Medicinal Products" - Consensus Information Paper Scope: issues NOT covered: Interchangeability Substitution Switching "The decisions on interchangeability and/or substitution rely on national competent authorities and are outside the remit of the EMA/CHMP [European Medicines Agency/ Committee for Medicinal Products for Human Use]. Member States have access to the scientific evaluation performed by the CHMP and all submitted data in order to substantiate their decisions." * * (Page 33/33 of EMA Procedural advice for users of the centralised procedure for similar biological medicinal products applications - EMA/940451/2011). 6 3
"What you need to know about Biosimilar Medicinal Products" Consensus Information Paper Content: Concept of biologicals and biosimilars, the process and scientific rational behind their approval. Economic consequences. Questions and Answers for specific target groups: patients, physicians, payers. Key messages: Biosimilars follow the biosimilar pathway which include defined high standards of quality, safety and efficacy. "A biosimilar medicinal product and its reference medicinal product are expected to have the same safety and efficacy profile". "Biosimilar medicinal products have been used safely in clinical practice in the European Union since 2006 and their market share has been growing at different rates across both EU Member States and product categories". 7 Consensus information paper benefits of biosimilars: main messages The availability of biosimilar medicinal products: enhance competition; can improve patient access to biological medicines; can contribute to the financial sustainability of EU healthcare systems. 8 4
Next steps 1. Transparency Directive: continuation of the negotiation. 2. General framework: forthcoming industrial policy initiative for the pharma sector. 3. Biosimilars specific initiatives (follow-up of the Process). 9 2014: Pharmaceutical Industry Initiative - European Council conclusions of March 2014: "Europe needs a strong and competitive industrial base, in terms of both production and investment, as a key driver for economic growth and job". - Commission Industrial Policy Communication 2012: "policy strategy agenda to strengthen the competitiveness of the pharmaceuticals industry": Major drivers and challenges. European response. Integrated approach bringing together all stakeholders (public/private EU/MS): decision-makers from public bodies in charge of health, industrial competitiveness, pricing and reimbursement at Member States level, their Commission counterparts, patients, healthcare professionals and industry representatives. 10 5
Biosimilar specific follow-up of the Process Monitoring of Biosimilars' evolution through regular meetings and exchange of information amongst MS and stakeholders (organised by EC with all stakeholders) on: New market dynamic (e.g. trends in market penetration) New developments (e.g. following the approval of the first biosimilar monoclonal antibody) Awareness raising and information. 11 Thank you! Final documents are available at the Commission website: http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/p rocess_on_corporate_responsibility/platform_access/index_en.htm 12 6