Biosimilars applications under review by EMA

Biosimilars applications under review by EMA – December 2014 Posted 30/01/2015

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

All medicines for human and animal use derived from biotechnology and other high-tech processes (including biosimilars) must be approved via the centralized EMA procedure. EMA has both general and product specific guidelines giving information on the requirements for biosimilar applications submitted to EMA [1].

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP) released on 6 January 2015 the agency is reviewing two biosimilar applications. One application is for diabetes treatment, human insulin. An insulin glargine biosimilar, Abasaglar (previously Abasria), was approved in the EU on 9 September 2014 [2]. The other application is for arthritis treatment etanercept, for which there are currently no biosimilars available on the European market [3], see Table 1.

Table 1: Biosimilars under review by EMA*

Common name	Therapeutic area	Number of applications	Originator product	Originator company
Etanercept	Immunosuppressant	1	Enbrel	Amgen
Human insulin	Diabetes	1	Insuman	Sanofi
Total		2
*Data collected on 22 January 2015 Source: EMA

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 21 January 2015 that its etanercept biosimilar candidate, SB4, had been accepted for review by the European Medicines Agency (EMA) [4]. This is the first application for an etanercept biosimilar to be accepted for review by EMA.

The patents on the originator product Enbrel (etanercept) are set to expire in Europe in February 2015, but will only expire in the US in November 2028 after Amgen was granted a new patent [5, 6].