Changes in requirements for reference products for biosimilars

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In her presentation [1] at the 14th Annual Biosimilar Medicines Group Conference, Dr Martina Weise, Head of the Licensing Division at the Federal Institute for Drugs and Medical Devices (BfArM), discussed the changes in data requirements introduced in the European Union (EU) since it first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006.

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With respect to reference products for biosimilars, one major change is that a reference product not authorized in the European Economic Area* (EEA) may be used for certain clinical and in vivo non-clinical studies if it was authorized based on similar scientific and regulatory standards as those used by European Medicines Agency (EMA) and if it is representative of the reference product in the EEA [2]. This is outlined in EMA’s Guideline on similar biological medicinal products (CHMP/437/04 Rev 1. Effective date: 30 April 2015) [3].

The only catch is that applicants will have to prove that batches sourced from outside the EEA are representative of the reference medicine authorized in the EEA through an extensive analytical comparison. Bridging data must include a 3-way analytical comparison (structural and functional data) and may include a 3-way pharmacokinetic (PK) and/or pharmacodynamic (PD) comparison.

Requirements for reference products in the EU and US are comparable.

*EEA: European Economic Area, this area includes the 28 EU Member States, plus Iceland, Liechtenstein and Norway.

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

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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.
2.  GaBI Online - Generics and Biosimilars Initiative. EMA to accept biosimilar reference medicines from outside EEA []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from:
3.  GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from:

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