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EMA enables use of foreign reference product to facilitate biosimilars development in the EU

01 December 2014 Federica Benassi

With the recent publication of the revised overarching guideline on biosimilar medicines, the European Medicines Agency (EMA) has formally introduced the possibility for biosimilar drug manufacturers to use a reference product approved for commercialisation outside the European Economic Area (EEA) - which includes the 28 EU member states as well as Iceland, Liechtenstein and Norway - during the clinical investigation of a biosimilar medicine. This is one of the main changes brought by the new version of the guidance, which replaces the previous guideline published in 2005. In fact, the possibility to use reference product approved in other markets is expected to facilitate and expedite the development process for companies interested in seeking approval in EEA markets.

EU follows in Canada's footsteps on biosimilars
Although the use of a reference medicinal product approved in one of the EEA countries remains the standard procedure, the EMA provides manufacturers with the opportunity to "compare the biosimilar in certain clinical studies and in in vivo non-clinical studies (where needed) with a non-EEA authorised comparator… which will need to be authorised by a regulatory authority with similar scientific and regulatory standards as the EMA". Preferred reference products are medicines approved in countries that have adopted the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines. The guidance formalises an announcement made by former EU Commissioner John Dalli in 2012 on the intention of the EMA to start accepting batches of reference medicines sourced from countries outside the EEA.

With this relaxing of the requirements for reference product, the EMA has decided to follow the same path as Canada; in fact, in 2010 Health Canada published an overarching guidance on subsequent entry biologics (SEBs) that established for the first time the possibility for a biosimilar drug producer to use as a reference biologic not approved in Canada. Furthermore, similar to the requirements laid out by the Canadian authority, the EMA underlines that it is responsibility of the applicant to demonstrate the foreign biologic drug used for the purposes of demonstrating similarity is a suitable proxy for the version of the product approved in the EEA.

Positive reaction from the biosimilars industry
The document has been unsurprisingly well received by the European Biosimilars Group (EBG), part of the European Generic Medicines Association (EGA); the provisions introduced are expected to foster biosimilar drugs development, since the use of reference products approved outside the EEA will allow companies not to repeat costly clinical trials to have the same biologic drug approved by the European Commission. This is likely to make the European market more accessible for biosimilar drug producers.

There are currently 19 biosimilar medicines approved for use in EEA markets. The guideline is one of three overarching EMA guidelines on biosimilars; the agency has also approved a revised guideline addressing the quality issues related to biosimilar development which will come into effect in December 2014 and a guideline on the clinical and non-clinical aspects related to biosimilar development that is expected to be published by the end of 2014.

The text will officially come into force on 30 April 2015, but it leaves open for applicants the possibilities to apply some or all of the provisions from the day of publication of the new text.

As I underlined in a previous blogpost, biosimilars are gaining increasing shares of the pharmaceutical market in Europe and are expected to continue to grow going forward. National governments in the EU continue to look with interest to the development of the biosimilars market as a measure to reduce pharmaceutical spending pressure on the public healthcare budget.

Federica Benassi is a life sciences analyst for IHS
Posted on December 1, 2014



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