and evolution and to embed regulatory and policy frameworks in a timely and responsible manner. There will also continue to be greater economic pressures from governments and payers of all political persuasions for affordable biologics like biosimilars to realize the full benefits of innovator biologic medicines. It is therefore imperative that pharmacists keep abreast of such rapid changes in the information as they will be expected to lead discussions with doctors and patients on these important therapeutic agents.
Table 1.4 Abbreviations used in biologic medicine literature.
| Abbreviation | Full name |
|---|---|
| ADCs | Antibody–Drug Conjugates |
| ADR | Adverse Drug Reaction |
| ADE | Adverse Drug Event |
| AE | Adverse Event |
| ANDA | Abbreviated New Drug Application |
| ARTG | Australian Register of Therapeutic Goods |
| ATMP | Advanced Therapy Medicinal Products |
| BDMARDs | Biologic Disease‐Modifying Anti‐Rheumatic Drugs |
| BIA | Budget Impact Analysis |
| BLA | Biologics License Application |
| BPCI Act | Biologics Price Competition and Innovation Act |
| CAPs | Centrally Authorised Products (EU) |
| CAR‐T | Chimeric Antigen Receptor Therapy |
| CDMO | Contract Development and Manufacturing Organisation |
| CEOR | ClinicoEconomics and Outcomes Research |
| CHMP | Committee for Medicinal Products for Human Use (EMA) |
| CIOMS | Council for International Organizations of Medical Sciences |
| CE | Comparability Exercise |
| CMA | Critical Material Attribute |
| CPP | Critical Process Parameter |
| CQA | Critical Quality Attribute |
| CTD | Common Technical Document |
| DCP | Decentralised Procedure |
| DDD | Defined Daily Dose |
| DDR | Dose‐Dense Regimens |
| EC | European Commission |
| EMA (EMEA) | European Medicines Agency |
| EPARs | European Public Assessment Reports |
| EPO | Erythropoietin (epoetin) |
| EU | European Union |
| Eudra | European Drug Regulatory Authorities |
| FDA | Food and Drug Administration |
| FD&C | Food, Drug, and Cosmetic |
| FTC | Federal Trade Commission (in the United States) |
| GCP | Good Clinical Practice |
| GH | Growth Hormone |
| GMP | Good Manufacturing Practice |
| GVP | Good Pharmacovigilance Practice |
| HCPCS | Healthcare Common Procedure Coding System |
| HPLC | High‐Performance Liquid Chromatography |
| IBD | Inflammatory Bowel Disease |
| ICH | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
| INN | International Non‐proprietary Name |
| IP | Intellectual Property |
| LDN | Limited Distribution Network |
| LMWH | Low Molecular Weight Heparins |
| MA | Marketing Authorisation |
| MAA | Marketing Authorisation Application |
| MCOs | Managed Care Organisations |
| MR | Mutual Recognition |
| NHS | National Health Service |
| NDA | New Drug Application |
| NMS | Non‐Medical Switching |
| NICE | National Institute for Clinical Excellence (UK) |
| mAb | Monoclonal Antibody |
| PBAC | Pharmaceutical Benefits Advisory Committee |
| PBS | Pharmaceutical Benefits Scheme |
| PFS | Pre‐Filled Syringe |
| PHS | Public Health Service |
| PMS | Post‐Marketing Surveillance |
| PPRS |
Pharmaceutical Price
|