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

Published in: Volume 6 / Year 2017 / Issue 4
Category: Special Report
Page: 183-4
Visits: 220 total, 2 today
Keywords: Biosimilar, EMA, interchangeability
This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders and biosimilars makers and could be delaying access to life-saving treatments.

Submitted: 5 December 2017; Revised: 7 December 2017; Accepted: 8 December 2017; Published online first: 21 December 2017

There are some major differences between USA and Europe regarding how they view interchangeability of biologicals/biosimilars. In fact, there is a lack of harmonization around the world when it comes to how different countries or regions approach interchangeability of biosimilars [1].


In the US, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) creates an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with a 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’.

FDA defines interchangeability as:
• the biological product is biosimilar to the reference product;
• it can be expected to produce the same clinical result as the reference product in any given patient; and
• for a product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the product and its reference product is not greater than the risk of using the reference product without such alternation or switch.

FDA may approve a biological product as interchangeable, see Table 1. Although individual states control the act of pharmacy-level substitution. The agency issued draft guidance on interchangeability in January 2017 [2] and more recently extended the comment period on the guidance [3].

Table 1 pending to upload

As of 1 July 2017, 35 states and Puerto Rico have passed laws allowing substitution by a pharmacist if the biosimilar is considered interchangeable and is covered under an insurer’s pharmacy benefit [4]. However, despite issuing draft guidance on interchangeability in January 2017 [2], to date FDA has yet to approve a biosimilar as interchangeable with its reference biological.

European Union

The European Commission (EC) has defined interchangeability in a consensus information document on biosimilars [5] 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’.

Substitution is considered to be:
• An administrative measure
• The practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber

In the EU, decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency (EMA), but at the national level, see Table 1. This is the case, despite the fact that biosimilars developed in line with EU requirements are considered by EMA to be therapeutic alternatives to their reference biologicals [6].

Automatic substitution of biosimilars is therefore not routinely practised in Europe, although in some Member States the use of biosimilars has been actively facilitated by national and local tender systems.

Competing interests: None.

Provenance and peer review: Article abstracted based on published scientific or research papers recommended by members of the Editorial Board; internally peer reviewed.

Michelle Derbyshire, PhD, GaBI Journal Editor

References pending to upload

Disclosure of Conflict of Interest Statement is available upon request.

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