Considerations for real-world research on biosimilars

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In a presentation on ‘Biosimilar Considerations for Real World Research and Stakeholder Questions’ at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 23‒24 September 2019 in Bethesda, Maryland, USA, considerations for real-world research on biosimilars were discussed by Dr Jaclyn Bosco of IQVIA. These include:

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Access and distribution
• Biologicals can be self-administered or infused by a healthcare provider
• Tracking distribution can depend on what is being used and how it is being supplied

Dosing and administration
• Indication-specific dosing and starter doses need to be considered
• Each product has a different dosing schedule and time period it covers
• Complexities in tracking dosing, especially for hospital data (infusions)

Reimbursement and coverage
• Affects who received the originator or biosimilar in each market
• Affects the ability to enrol patients into real-world studies

Interchangeability and substitution
• Decisions regarding interchangeability and automatic substitution vary by regulatory agency and local legislation
• May affect ability to classify patients exposed to biosimilar of interest

For example, in the US, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) creates an abbreviated licensure pathway for biologicals shown to be biosimilar to or interchangeable with a US Food and Drug Administration (FDA) licensed reference product. Interchangeability is defined in law as part of the BPCI Act as ‘the biological product may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product’ [2].

However, in Europe, decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency, but at the national level. The European Commission has defined interchangeability in a consensus information document on biosimilars [3] as ‘the medical practice of changing one medicine for another that is expected to achieve the same clinical effect in a given clinical setting and in any patient on the initiative, or with the agreement of the prescriber’ [2].

Naming and coding conventions
• No global harmonization in naming conventions
• May affect ability to identify patients on the biosimilar of interest from secondary data sources

The World Health Organization (WHO) has introduced the concept of a biological qualifier (BQ). In the European Union, both the brand name and International Nonproprietary Name (INN) are used to identify the specific biological product, whether it is an originator product or a biosimilar. Japan’s policy includes the INN of the reference product, with a biosimilar qualifier and a code for the order of approval. FDA, on the other hand, has decided that all biologicals and biosimilars should have non-proprietary names and that a 4-letter suffix be added to the names to distinguish them from each other [4]. Whereas, Health Canada has decided that biological drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix [5].

Market uptake
• Adoption of biosimilars may vary by region and therapeutic specialty
• May be driven by reimbursement and health insurance coverage
• Contemporaneous comparators may be difficult to identify or may change over time

Related article
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Uptake of biosimilars in different countries varies

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1. Bosco J. Biosimilar considerations for real world research and stakeholder questions. DIA Biosimilars Conference; 2019 Sep 23‒24; Bethesda, Maryland, USA.
2. Derbyshire M. USA and Europe differ in interchangeability of biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(4):183-4. doi:10.5639/gabij.2017.0604.039
3. GaBI Online – Generics and Biosimilars Initiative. Integrating biosimilars into clinical practice []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from:
4. GaBI Online – Generics and Biosimilars Initiative. Biosimilar naming conventions around the world []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from:
5. GaBI Online – Generics and Biosimilars Initiative. Health Canada announces naming convention for biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 4]. Available from:

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