EuropaBio "Guide to Biological Medicines" Stefan Bergunde, Biosimilars Topic Group Leader, Europabio

Transcription

1 EuropaBio "Guide to Biological Medicines" Stefan Bergunde, Biosimilars Topic Group Leader, Europabio 1st EuropaBio ASEBIO meeting on Innovation and Biological Therapies - 25th of November Madrid Background At EU level in 2013: Consensus Information Document to provide basic information on biological medicines and biosimilars to lay persons Overview reimbursement status of authorised biosimilars in MS and EFTA countries; Study on biosimilar market in Europe (size and growth) A number of important issues not discussed in the above EuropaBio = manufacturers of both novel biologics AND biosimilars 2 1

2 EuropaBio Guide content overview 1. Set the scene (5 basic facts about biologics, incl. biosimilars) 2. Objectives of the paper 3. Priority issues for EuropaBio members: a. Naming b. Labelling c. Prescribers choice (innovator / biosimilar substitution) 4. Call for action 3 1. Setting the scene 5 facts 1. Biologics are produced from living systems = highly sensitive to minor changes in physiological environment thus difficult to characterise and replicate 2. Size of biologics = single molecule on average times bigger than a chemical synthesised API 3. Complex and highly controlled manufacturing process = genetically modified cell lines grown in bioreactors, extracted & purified 4. Centralized authorisation (EMA) but no recommendation on interchangeability and/or substitution; national competence 5. Biosimilar Market = biosimilars still small but growing fast 4 2

3 2. Objectives 1. Explain why Europe needs to continue to maintain high standards for biosimilars (internally and around the globe) 2. Stress the need for: Distinguishable non-proprietary names for all biological medicines to enhance traceability; Transparent information in biosimilar labels, to facilitate physician and patient understanding as well as respect for physicians prescribing authority; Appropriate terms of use in patient care particular for well-treated patients. 5 3.a Priority Issues: Naming Situation: Globally non-proprietary names assigned upon request (voluntary INN system) Original biologic medicine and all approved distinct biosimilars can share the same INN, whether they have structural differences or not EU Pharmacovigilance framework requires Brand Name and Batch Number Identification If a doctor reports adverse drug reactions by INN (as recent surveys suggest) there is a risk the collected adverse events may be inappropriately attributed to the wrong manufacturer EuropaBio suggestion: Develop distinguishable non-proprietary names for all biological medicines, including biosimilars (eg, WHO Biological Qualifier) Product-level traceability within and outside Europe 6 3

4 3.b Priority Issues: Labelling Situation: Today the labelling of a biosimilar must be identical to that of the reference product (unless otherwise justified) = same approach as for generics No information provided to physicians about : how the biosimilarity exercise was built up which additional data was generated to show proven safety and efficacy of the reference product also apply to the biosimilar EuropaBio suggestion: Develop a specific label for biosimilars, including data about the originator and specific pre-clinical and clinical data from the distinct biosimilar Transparent labelling will facilitate understanding & acceptance & crucial for physicians to make informed decisions on drug choice 7 3.c Priority Issues: Freedom of Choice Situation: Decisions on automatic / pharmacy substitution of biologic medicines is Member State responsibility As of today, no EU MS has explicitly authorised substitution, and many MS have prohibited it EuropaBio suggestion: Decision should remain MS competence, BUT physician s supervision is crucial as not all biosimilars will necessarily have all the same indications, or the same administration devices as their reference medicine For stable and well-treated patients specific needs and potential negative consequences should be considered 8 4

5 4.a Call for action - Europe 1. Further strengthen measures to support accurate adverse event reporting in particular the correct attribution of an adverse event to a product 2. Share best practice for the identification and traceability of biologics 3. Ensure transparent labelling for biosimilars 4. Enhance the education of physicians, healthcare professionals and patients on the specificities of biosimilars 9 4.b Call for action MS (e.g. Spain) 1. Take into account the specificities of biosimilars in national regulatory frameworks 2. Prevent non-medical substitution 3. Make sure continuity of patients treatments and physicians authority to prescribe take precedence over austerity policy measures 4. Involve all interested parties in any policy debate related to the uptake of biosimilars 5. Recommend physicians to prescribe all biologics including biosimilars by brand (trade) name only 6. Enhance stakeholder education on biosimilars and their complexity 10 5

6 4.b Call for action Doctors & Patients Physicians to: Prescribe medicines that best suit patient needs and by brand (trade) name Inform patients about specifics of biological medicines Maintain their prescribing authority Report the brand name, the batch number and the INN of the biological medicine in case of adverse events Patients to: Pay attention that the biological medicine delivered by the pharmacist always corresponds to what was prescribed by a physician through all phases of the treatment Contact national patient group(s) to obtain further information on biosimilars or consult patient Q&A section of Consensus Information Document / IAPO s Toolkit on biosimilars 11 EuropaBio resources - biosimilars EuropaBio Guide EuropaBio Position Paper EuropaBio Statement on labelling About EU Consensus Information Document : Presentation Briefing Paper Q&A 12 6