The European Medicines Agency (EMA) is constantly issuing new guidelines and updating its existing guidelines based on new evidence and rapid advances in analytical sciences. Changes introduced by EMA since the agency first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006 have included how the agency considers requests for extrapolation** of indications for biosimilars and pharmacovigilance requirements.

Extrapolation
Regarding extrapolation** of indications for biosimilars, EMA has stated that ‘if clinical similarity can be shown in a key indication, extrapolation of efficacy and safety data to other indication(s) of the reference product may be possible’ under certain conditions [1].

In her presentation Dr Weise explained that extrapolation:
• Should be considered in the light of the totality of data supporting biosimilarity
• Changed from ‘situations where extrapolation may be considered’ to ‘situations where additional data may be required’:
– If different active sites of the molecule or different receptors involved in different indications
– Efficacy and/or safety (immunogenicity) data are not relevant for extrapolated indication(s)

Pharmacovigilance
New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. EMA is responsible for implementing the legislation. As part of its commitments the agency released draft guidance on pharmacovigilance for biologicals in December 2015 for public consultation. This guideline has since been finalized and came into effect in August 2016.

Guideline on good pharmacovigilance practices (GVP)
Product- or Population-Specific Considerations II: Biological medicinal products
Effective Date: 16 August 2016
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211728.pdf

The guideline outlines the following:
• Risk-management plan obligatory:
– Needs to be in line with the risk-management plan of the reference product
– Deviations in risk-minimization measures or safety monitoring imposed on the reference product must be justified
– Encouragement to participate in pharmacoepidemiological studies of the reference product
• Ensure product traceability:
– Product name and batch number should always be recorded
– Data from EudraVigilance suggest good identification by brand name

_{**Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition.}

Disclaimer
The author of the presentation [1] declared that the views and opinions expressed in the presentation were personal views, and may not be understood or quoted as being made on behalf of the Committee for Medicinal Products for Human Use (CHMP) or reflecting the position of the CHMP or any other EMA Committee or Working Party.

Conflict of interest
The author of the presentation [1] did not provide any conflict of interest statement.

Editor’s comment
Readers interested in contributing a research paper in a similar area to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

If you would like to receive a PDF copy* of the Weise presentation [1], please send us an email.

_{*For profit organizations subjected to a fee}

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Demonstrating biosimilarity in the EU

Reference
1. Weise M. Evolving landscape on data requirements to demonstrate biosimilarity – the EU perspective. 14th Annual Biosimilar Medicines Group Conference. 28–29 April 2016; London, UK.

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