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. PrescQIPP provides 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