suffix. Thus, each biologic has a unique, distinguishable name in the United States.
Europe, Australia, and Canada have adopted a different naming approach that incorporates distinguishable suffixes. These countries allow biologics including biosimilars to share nonproprietary names but have strengthened adverse event monitoring by either mandating inclusion of brand names or nonproprietary names as well as brand names in adverse event or pharmacovigilance reporting. In Australia, for example, the product's trade name, as well as the nonproprietary name, is a mandatory field when reporting an adverse event.60
The naming of biosimilars has implications far beyond the marketing and commercial sphere; it may directly affect patients’ confidence in switching to biosimilars and traceability of each biosimilar product with respect to its efficacy and safety monitoring once on the market.
1.8 Listing of Approved Biologics
1.8.1 Purple Book in the United States
The Purple Book is a compendium of FDA‐approved biological products and their biosimilar and interchangeable products. It resembles the Orange Book, which is a list of approved SMD generics. Information on each product listed in the Purple Book includes its BLA tracking number, product name, product proprietary name, date of licensure, date of first licensure, reference product exclusivity expiration date, indication as to whether the product is interchangeable (I) or biosimilar (B), and whether the product was withdrawn from the market.61 Other countries have similar lists of approved innovator biologics and biosimilars.
1.8.2 European Generic Medicines Association (EGA) Biosimilars Handbook
This handbook provides information on the current state of biosimilar medicines in the EU. It describes the science and technology behind biosimilar medicines, how they are produced and regulated, and provides answers to many specific questions. These include the terminology used, the meaning of “quality, efficacy and safety” and “comparability,” the purposes and methodologies of nonclinical and clinical tests and trials, the role of pharmacovigilance and risk management, and the significance of immunogenicity. Access to medicines, including substitution, interchangeability, and the importance of identification is also included.62
1.9 Biosimilar Initiatives and Organizations
Many initiatives and organizations with interest in broader adoption of biosimilars have come into being, driven by governments and/or private organizations and agencies including patient advocacy groups. A summary of these is provided as these initiatives and organizations affect the information flow and influence the uptake of innovator biologics and biosimilars. The intent here is not to discuss comprehensively every national or international initiative on the adoption of biosimilars but to present some prominent exemplars so that the reader is able to map to similar national and local initiative(s) in their own country. If such initiatives are not currently available in a country, then the reader may also be able to facilitate the creation of such an initiative tailored to the specific needs of their country.
1.9.1 Generics and Biosimilars Initiative (GaBi/GaBI)
Generics and Biosimilars Initiative (GaBi/GaBI) was founded in 2008. The mission of GaBI is to foster the efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable, and sustainable health care internationally.
GaBI aims to raise the scientific status of SMD generics and biosimilar medicines and to provide comprehensive high‐quality, scientifically sound, reliable, well‐documented, and up‐to‐date information about generics and biosimilar medicines in both print and electronic media in an open‐access format. To this end, GaBI provides a service for healthcare providers to support them in making cost‐effective choices when it comes to treatment option decisions. Physicians and pharmacists are the primary target of GaBI, followed by healthcare policymakers and drug regulators, third‐party insurers, and pharmaceutical/ biotech industry.63 This initiative has GaBI Online and GaBI Journal as its principal resources.
1.9.2 Biologics Price Competition and Innovation Act in the United States
The US Congress passed the Biologics Price Competition and Innovation (BPCI) Act in 2009, authorizing the FDA to oversee an “abbreviated pathway” for approval of biologics that are “biosimilar” to already approved biologic products.64 The BPCI Act (also known as the Affordable Care Act) aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary testing.
Under the BPCI Act, a sponsor may seek approval of a “biosimilar” product. A biological product may be demonstrated to be “biosimilar” if data show that the product is “highly similar” to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency.
In order to meet the higher standard of interchangeability, a sponsor must demonstrate that the biosimilar product can be expected to produce the same clinical result as the reference product in any given patient and, for a biological product that is administered more than once, that the risk of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of maintaining the patient on the reference product. Interchangeable products may be substituted for the reference product by a pharmacist without the intervention of the prescribing health‐care provider.
The BPCI Act intended to facilitate timely approval of and access to biosimilars to US citizens. Recent evidence appears to suggest that this goal has not been achieved and other essential steps are required.2,65
1.9.3 Biosimilars Action Plan (USFDA)
In July 2018, the USFDA published its Biosimilars Action Plan, BAP.66 Key elements of the BAP include (i) improving the efficiency of the biosimilar and interchangeable product development and approval process; (ii) maximizing scientific and regulatory clarity for the biosimilar product development community; (iii) developing effective communication to improve understanding of biosimilars among patients, clinicians, and payers; and (iv) supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay biosimilar competition.
1.9.4 NHS England Commissioning Framework for Biological Medicines
NHS England released this framework in late 2017. This document supports NHS commissioners to act promptly to make the most of the opportunity presented by increased competition among biological medicines, including biosimilars. In particular, this framework sets out the importance of taking a collaborative approach to the commissioning of innovator biologics and biosimilars.67 A companion commentary on preparing for the biologic switch is also available.68
1.9.5 PrescQIPP
PrescQIPP is a UK NHS funded not‐for‐profit organization that supports quality optimized prescribing for patients. It helps NHS organizations to improve medicines‐related care to patients, through the provision of accessible and evidence‐based resources.69 PrescQIPP also provides a platform to share innovation, learning, and good practice. It operates for the benefit of NHS patients, commissioners, and organizations.
