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Abbreviations

Оглавление
Abbreviation Full name
ABPI Association of British Pharmaceutical Industry
AfPA Alliance for Patient Access
BAP Biosimilars Action Plan
BLA Biologics License Application
BPC Biologics Prescribers Collaborative
BPCI Act Biologics Price Competition and Innovation Act
CAR‐T Chimeric Antigen Receptor Therapy
CHMP Committee for Medicinal Products for Human Use (EMA)
CIOMS Council of International Organizations of Medical Sciences
CQAs Critical Quality Attributes
CVMP Committee for Medicinal Products for Veterinary Use
Da Dalton
DNA Deoxyribonucleic Acid
EMA European Medicines Agency
EPAR European Public Assessment Report
EU European Union
FDA Food and Drug Administration
GABi/GaBI Generics and Biosimilars Initiative
LDN Limited Distribution Network
mAbs monoclonal Antibodies
NHS National Health Service
NICE National Institute for Clinical Excellence
NMS Non‐Medical Switching
NOBs Non‐Original Biologics
PBS Pharmaceutical Benefits Scheme
P&T Pharmacy & Therapeutics (Committee)
PTMs Post‐Translational Modifications
QbD Quality by Design
QUM Quality Use of Medicine
RMP Risk Management Plan
RPS Reference Product Sponsor
RWE Real‐World Evidence
SEBs Subsequent‐Entry Biologics
SMD Small Molecule Drug
UMC Uppsala Monitoring Centre
UNESCO United Nations Educational, Scientific and Cultural Organization
USA United States of America
USD US Dollar
WHO World Health Organisation

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