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Rift-lines within European regulatory framework for Biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account formatIsbn:Softcover - 9783656517399 In der allgemeinen Diskussion herrschtMaster's Thesis from the year 2013 in the subject Medicine Pharmacology, grade: 1 st CLASS HONS, Dublin Institute of Technology (Chemistry), course: Pharmaceutical Quality Assurance Regulatory Affairs, language: English, abstract: During the course of this thesis evidence was presented and discussed related to the research questions. The fundamental question related to the heterogeneity and variation through the life cycle of the biosimilar and the