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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
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 Regulation Scheme (UK)
QbD	Quality by Design
RCT	Randomised Clinical Trial
REMS	Risk Evaluation and Mitigation Strategies
RMOCs	Regional Medicines Optimisation Committees (UK)
RMPs	Risk Management Plans
RMR	Reaction Monitoring Report
RPG	Reference Price Group
RWD	Real‐World Data
SB	Synthetic Biology
SEBs	Subsequent‐Entry Biologics
SBPs	Similar Biotherapeutic products
SMDs	Small molecule Drugs
SmPAR	Summary of Pharmacovigilance Assessment Report
SmPc	Summary of Product Characteristics
SPBs	Similar Protein Biotherapies
TGA	Therapeutic Goods Administration
TPP	Target Product Profile
TPQP	Target Product Quality Profile
WHO‐UMC	World Health Organization‐Uppsala Monitoring Centre

The subsequent chapters of this book are pitched explicitly to pharmacists and doctors and deal in greater detail with the various scientific, clinical, economic, QUM, and pharmacovigilance aspects of innovator biologics, biosimilars, and biobetters. The material provided in this and subsequent chapters should facilitate discussions by pharmacists with doctors and patients on these expensive and highly effective medicines so that the full therapeutic potential of all biologic medicines is realized in a timely manner.