By European Generic Medicines Association
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Additional info for Biosimilars Handbook
The registration dossier includes all the necessary data to establish the quality of the product, including: • Deﬁnitions and descriptions of the manufacturing process, and associated control tests and standards • Data on the consistency of manufacturing (quality control of the process) • Data on analytical tests (molecular structure, potency and purity/impurity proﬁle) • Data on stability of the product Most of the above data would be presented as a comprehensive comparability exercise with the reference product.
The Patient Protection and Affordable Care Act (PPACA). 37 | biosimilars handbook There is a need to reach agreement on criteria and guidelines for biosimilar medicines all over the world in the interest of public health and better availability of high quality medicines. WHO GUIDELINE The World Health Organization (WHO) published the ﬁnal guidelines on evaluation of similar biotherapeutic products (SBPs) in April 20109. The basic scientiﬁc principles underlying the WHO guideline are the same as those in the EU guidelines.
The term ‘automatic substitution’ refers to the practice whereby the pharmacist is obliged to dispense one medicine instead of another equivalent and interchangeable medicine due to national or local requirements 45 | biosimilars handbook acronyms and abbreviations BMWP Working Party on Similar Biological Medicinal Products (EMA) BPCI Act Biologics Price Competition and Innovation Act BWP Biotechnology Working Party (EMA) CHMP Committee for Medicinal Products for Human use (EMA) EC European Commission EEA European Economic Area EGA European Generic medicines Association EMA European Medicines Agency EPAR European Public Assessment Report EPO Erythropoietin EU European Union FSH Follicle Stimulating Hormone G-CSF Granulocyte-Colony Stimulating Factor GDP Gross Domestic Product GMP Good Manufacturing Practice INN International Non-proprietary Name LMWH Low Molecular Weight Heparin mAb Monoclonal Antibody NCA National Competent Authority PD Pharmacodynamic(s) PK Pharmacokinetic(s) PASS Post-Authorisation Safety Studies PPACA Patient Protection and Affordable Care Act PSUR Periodic Safety Update Reports RMP Risk Management Plan WHO World Health Organization 46 | biosimilars handbook references 1 Alan Sheppard, IMS: Presentation at EGA Biosimilar Medicines Symposium 2008: Biological/Biotechnological Pharmaceuticals and Biosimilars 2 Scrip-World Pharmaceutical News–17 September 2007 (Ref.
Biosimilars Handbook by European Generic Medicines Association