suitable medicines if a medicine is considered necessary and ensuring that patients and carers have the knowledge and skills to use medicines safely and effectively. QUM concepts apply equally to decisions about medicine use by individuals as well as decisions that affect the health of the population.
QUM concepts and principles as they apply to innovator biologics and biosimilars is the subject of a detailed discussion in Chapter 14.
1.10.8 European Public Assessment Report
EMA publishes detailed information on the medicines assessed by the Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) which are granted (or refused) central marketing authorization by the European Commission. The main vehicle for this information is known as a European Public Assessment Report (EPAR), which is a full scientific assessment report of medicines authorized in the EU.
An essential role of the EPAR is to reflect the scientific conclusions of the relevant EMA committee at the end of the assessment process, providing the grounds for the expert opinion on whether to approve an application.
EPARs are updated periodically to reflect the latest regulatory information on medicines. If the original terms and conditions of a marketing authorization are varied, the EPAR is updated to reflect such changes with an appropriate level of detail.
EPARs are a valuable source of information about innovator biologics and biosimilars.85
1.11 Abbreviations Associated with Biologic Medicines
Many abbreviations relating to innovator biologics, biosimilars, and biobetters are used in the literature by many and varied stakeholders. A summary of these frequently used abbreviations is presented in Table 1.4 to familiarize readers with these terms and abbreviations.
1.12 Concluding Remarks
The science behind innovator biologics, biosimilars, and biobetters are complex and the literature is changing rapidly. The scientific and clinical data are evolving at a much faster rate than the ability of pharmacists, doctors, other health practitioners and patients to keep pace with new information. Regulators, as well as policymakers, also find it challenging to keep pace with this change 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 |
