Jul 4

EMA Biosimilars Approvals

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

On 27 June 2014, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) had recommended granting of marketing authorization for a biosimilar insulin glargine product (LY2963016).

Eli Lilly and its partner Boehringer Ingelheim has produced the biosimilar insulin glargine, which will be called as Abasria (LY2963016). The drug is a biosimilar of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine).

To date, EMA has approved 21 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoietin, insulin and TNF-inhibitor, for use in the EU.

Two biosimilar approvals have been withdrawn; one for filgrastim in April 2011 and one for somatropin in May 2012, leaving a total of 19 biosimilars approved for use in Europe.



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