many resources on biologics and other high‐cost medicines (for example, on biosimilars of infliximab, insulin, and etanercept, respectively).
1.9.6 The Association of the British Pharmaceutical Industry
The UK government recognizes the Association of the British Pharmaceutical Industry (ABPI) as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including pricing schemes for medicines in the United Kingdom. The ABPI has partnerships with UK NHS on medicine‐related projects including innovator biologics and biosimilars.70
1.9.7 NHS Scotland
Healthcare Improvement Scotland, as part of NHS Scotland, has led a biosimilar medicines national prescribing framework to support the safe, effective, and consistent use of biosimilar medicines in Scotland.71
1.9.8 National Institute for Health and Care Excellence
National Institute for Health and Care Excellence (NICE) in the United Kingdom supports the managed introduction of biosimilar medicines as part of its key therapeutic topics and initiatives for medicines optimization. NICE has released a biosimilars position statement72 and also has a position statement on the assessment of biosimilars.73 NICE provides many other resources.
1.9.9 Australian Biosimilar Awareness Initiative
This initiative was announced in 2015 as part of the Australian Pharmaceutical Benefits Scheme (PBS) Access and Sustainability Package. The aim is to support awareness of, and confidence in, the use of biosimilar medicines for healthcare professionals and consumers.74
Several research activities like up‐to‐date literature review75 form part of the initiative; these aim to separate the evidence from commentary better; gather data on current awareness and attitudes toward innovator biologics and biosimilars in Australia; and identify critical issues, like barriers to uptake and use of biosimilars.
1.9.10 NPS MedicineWise (Australia)
Several important initiatives are in place in Australia to ensure the health community embraces the full potential of innovator biologics and biosimilars. Within this context, and under the stewardship of NPS MedicineWise, The Biologic and Biosimilar Medicines 2020 Forum was held in 2016, to maximize the opportunities these medicines present to the Australian healthcare system.76 The Australian National Medicines Policy provided a framework for the Forum to discuss the opportunities and challenges presented by the availability of both innovator biologic and biosimilar medicines. A broad range of perspectives from research, industry, government, medical, pharmacy, and consumer perspectives were considered. The expanding settings in which innovator biologics and biosimilars may be used was also taken into consideration including hospitals, specialist medical centers, primary care, community pharmacy, and nonclinical environments such as the home. The themes that emerged from the forum included: improving the evidence base; optimizing data capture; pharmacovigilance and naming conventions; and building stakeholder confidence and shared decision‐making through high‐quality information.
1.10 Common Terms Used in the Biologics Literature
This section intends to provide the reader with significant terms that are used in biologic medicine literature internationally.
1.10.1 Real‐World Evidence
Real‐world evidence (RWE) refers to data on the use of a drug product obtained outside of clinical trials.77 In other words, the efficacy and safety data collected from medical records, pharmacovigilance records, personal devices, or electronic health applications after the medicine has been marketed, i.e. data and evidence about the drug product that is gathered during its widespread clinical use.
Depending on their design, RWE studies may follow patients for several years, or study treatments in patients not included in clinical trials (e.g. in children, elderly patients, or patients with concomitant diseases) or in clinical indications not studied during clinical trials. RWE studies may enhance the broader adoption of biosimilars.78 Importantly, RWE studies must be carefully designed to yield credible, reproducible results using sound pharmaco‐epidemiological principles and practices.
1.10.2 Patent Dance
As mentioned, the BPCI Act in the United States provides for an elaborate process of information exchange, known as the “patent dance”79 between a biosimilar applicant and an innovator/reference product sponsor (RPS) intended to resolve potential patent disputes in an orderly and expeditious fashion. This procedure (patent dance) has strict timing and sequencing requirements and involves several rounds of information exchange between the innovator/RPS and the biosimilar applicant.
1.10.3 Evergreening
Evergreening refers to the use of various strategies for patent extension, of innovator biologics as also occurs for SMD innovator drugs to delay the introduction of their SMD generics. Among other outcomes, evergreening may limit timely availability of biosimilars and affect their price.80
1.10.4 Limited Distribution Network
The limited distribution network, LDN, which restricts the distribution channel for a drug to one or a very small number of distributors, can stifle competition for biosimilars and affect their price.81
1.10.5 Drug Tendering
The goal of pharmaceutical procurement is to purchase high‐quality products with reliable supplier service and the lowest possible price. One method to contain spending is tendering, a formal procedure using competitive bidding for a particular contract; tendering is used when equivalents for a specific medicine are available, and is defined as “any formal and competitive procurement procedure through which offers are requested, received and evaluated for the procurement of goods, works or services, and as a consequence of which an award is made to the tenderer whose tender/offer is the most advantageous”82. Drug tendering may influence biosimilar uptake and price.82
1.10.6 Pharmacy and Therapeutics Committees
Pharmacy and Therapeutics (P&T) committees exist in most hospitals and pharmacists are key members of such committees offering objective, unbiased information and advice on all aspects of drug use. Considerations of quality, cost (reimbursement), access, and procurement and interchangeability of biosimilars with innovator biologics83 will be even more important to P&T committees as new emerging and even more expensive biotherapies enter the market and hospitals and insurers and governments attempt to improve clinical care within enormous budgetary constraints.
1.10.7 Quality Use of Medicine
QUM involves improving medicine use, including prescription, non‐prescription, and complementary medicines, and medical devices by health professionals and decision‐makers as well as by consumers and the pharmaceutical industry.84 QUM is also known as rational drug use, responsible drug use, or appropriate use of medicines and includes:
Selecting management options
