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2 Approved Biologic Medicines and Biosimilars in Major Regulatory Jurisdictions
Prateek Jain
Independent Consultant, Toronto, Canada
KEY POINTS
Ensure consistent quality of biologics by controlling the manufacturing process.
Rigorous clinical studies are required in patients to demonstrate safety and efficacy of biologics.
Post‐approval monitoring of safety and efficacy via pharmacovigilance plans need to be in place for of all prescribed biologics in patients to generate “real‐world” clinical data.
Abbreviations
| Abbreviation | Full name |
| ADA | Adenosine Deaminase Deficiency |
| ADC | Antibody–Drug Conjugate |
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| BPCIA | Biologics Price Competition and Innovation Act |
| CBER | Center for Biologics Evaluation and Research |
| CDE | Center for Drug Evaluation |
| CDER | Center for Drug Evaluation and Research |
| CFDA | China Food and Drug Administration |
| COPD | Chronic Obstructive Pulmonary Disease |
| CTA | Clinical Trials Application |
| DO | Drug Organization (Japan) |
| DRG | Diagnosis‐Related Groups |
| EGRF | Endothelial Growth Factor Receptor |
| EMA | European Medicines Agency |
| EU | European Union |
| FDA | Food and Drug Administration |
| GCP | Good Clinical Practice |
| GLP | Good Laboratory Practice |
| GMP | Good Manufacturing Practice |
| HER‐2 | Human Epidermal Growth Factor Receptor‐2 |
| IDL | Import Drug License (China) |
| IL‐5 | Interleukin‐5 |
| IMS | Intercontinental Medical Statistics |
| IV | Intravenous |
| JAAME | Japanese Association for the Advancement of Medical Equipment |
| KIKO | Another Name for OPSR (Japan) |
| LLP | Lipoprotein Lipase Deficiency |
| mABs | Monoclonal Antibodies |
| MHLW | Ministry of Health, Labour and Welfare (Japan) |
| MIDAS | Market Information on Global Sales Activities (from IQVIA) |
| NASDAQ (Index) | National Association of Securities Dealers Automated Quotations (Index) |
| NOBs | Non‐Original Biologics |
| OPSR | Organization for Pharmaceutical Safety and Research |
| PCSK‐9 | Proprotein Convertase Subtilisin/Kexin type 9 |
| PMDA | Pharmaceuticals and Medical Devices Agency (Japan) |
| PMDEC | The Pharmaceuticals and Medical Devices Evaluation Center |
| R&D | Research and Development |
| SC |
