efpia回应-生物仿制药反思文件（2025年9月29日）

Fields marked with * are mandatory. Introduction to the survey on the draft Reflection paper on a tailored clinicalapproach in biosimilar development Please clickto be redirected to the guideline text. The public consultation is launched on 1 Aprilhere2025 until 30 September 2025. Those participating in the public consultation are asked to please submit comments via the EU Survey tool, byusing the specific table for each section. If you need more rows to be added to the table, please contact dora.duarte@ema.europa.euPlease note that login is not required to fill in the survey. Before submission, a draft of the comments can be saved in the EU Survey tool. Once submitted, commentscan be edited (by 30 September 2025) by clicking on "Edit contribution" in the link https://ec.europa.eu/eusurvey/ and entering your ID contribution that can be found on the pdf copy of your submission sent viaemail. When you have filled in the EU Survey, please use the submission button at the end of the form to submit thecomments to the European Medicines Agency. Data Protection Statement You are invited to provide your organisation or name, country and email address below for the purpose of thispublic consultation (for further information, please see EMA’s Data Protection Statement below). EMA Privacy Statement All personal data provided within this survey will be processed in accordance with Regulation (EU) 2018/1725on the protection of individuals regarding the processing of personal data by the Union Institutions and bodieson the free movement of such data. For more details on how EMA processes personal data, please refer to the EMA Data Protection Notice forsurveys conducted via EUSurvey: https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-data-protection-notice-conducting-surveys-eusurvey_en.pdfIf you have any questions, complaints or concerns about the processing of your personal data, you can contactEMA’s Data Protection Officer at dataprotection@ema.europa.euYou can contact the Internal Controller at datacontroller.humanmedicines@ema.europa.euYou may also lodge a complaint with the European Data Protection Supervisor: edps@edps.europa.eu Please confirm that you have read and understood the data protection notice and you consent to theprocessing of your personal data.* Yes Please confirm that you consent to possibly be contacted by EMA in relation to your survey responses tosupport the finalisation of the document subject this EU Survey.* YesNo Please confirm that you consent to the publication of your organisation name, your name (only if you do notrespond to the EU Survey on behalf of an organisation) and your survey responses on the EMA website at thetime of issuing the final guideline subject to this survey.* YesNo Should you not want to give consent to publish, please send your objections to datacontroller.humanmedicines@ema.europa.eu Please be aware that the sender of the comments is responsible to not disclose any personal data of thirdparties in the comments. For additional information, please consult.EMA’s privacy statement Your details Name of organisation or individual* European Federation of Pharmaceutical Industries and Associations Country of organisation or individual* Belgium Email* par.tellner@efpia.eu If you respond on behalf of an organization, please allocate yourself a name abbreviation to be used as"Stakeholder name" in the comment tables below. If you comment as an individual, please ignore this field anduse your full name as your "Stakeholder name". 1. General comments 1. General comments 2.2 Scope product · larger molecular size, active ingredient difficultto isolate · diverse moieties with different functions,complex mixtures · multiple mechanisms of action ·potential for immunogenicity and potentially life-threatening adverse effects (ADA incidence and/or themagnitude of ADA response including level ofneutralizing antibodies, and antibodies targetingendogenous substances, correlating with clinicalsequelae) 2 The knowledge of the RP · Sufficientbatches of RP can be analysed to reflect the variability ofthe RP over its shelf life · Analytical methods aresensitive, qualified and sufficiently discriminatory, withorthogonal methods used wherever possible · Range ofvariability is defined at analytical and in vitro functionallevels · Functional assays are relevant for the MoAs in allindications 3 The magnitude of differences expected incomparative structural and functional assessmentsmakes it difficult to predict the impact 4 The degree towhich the mechanism of action(s) is understood indifferent indications and how well these can beinvestigated in binding and functional in vitro tests ; Wellknown structure function relationship for everycomponent 5 The level of differences introduced in thebiosimilar compared to RP that could give rise topotential clinical/safety and immunogenicity concerns(change of manufacturing process impacting the impurityprofile