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Biosimilars applications reviewed in the EU

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The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006 the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].

In her presentation [3] 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 biosimilars applications reviewed by EMA.

Since EMA started reviewing applications for biosimilars, and up to April 2016, the agency had received 44 marketing authorization applications (MAAs). Of these, 13 were still under review and seven had been withdrawn (six for insulin biosimilars and one for an epoetin biosimilar). Up to April 2016, the agency had given a positive opinion for 22 MAAs, of which two were later withdrawn (filgrastim and somatropin), and a negative opinion for two MAAs (interferon alfa and insulin), see Figure 1.

Figure 1: Biosimilars review by EMA (until April 2016)

EMA: European Medicines Agency; MAAs: marketing authorization applications.

In May 2016, the infliximab biosimilar Flixabi received approval in the EU [1]. In November 2016, the EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for the teriparatide biosimilars, Terrosa and Movymia, and for the insulin glargine biosimilar Lusduna [4].

Disclaimer
The author of the presentation [3] 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 CHMP or reflecting the position of the CHMP or any other EMA Committee or Working Party.

Editor’s comment
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Tailored and reduced clinical programme for biosimilars

Changes in quality data and non-clinical studies for biosimilars

Changes in requirements for reference products for biosimilars

Demonstrating biosimilarity in the EU

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
3. 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.
4. GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilars of insulin glargine and teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilars-of-insulin-glargine-and-teriparatide

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