Regulatory Focus™ > News Articles > EMA to Allow Biosimilar Applications to Reference Data from Products Approved Outside EU

EMA to Allow Biosimilar Applications to Reference Data from Products Approved Outside EU

Posted 28 September 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) has announced its intent to accept clinical data from biosimilar medicines approved outside the European Economic Area (EEA), allowing companies an alternate and potentially easier route to obtain approval for new biosimilar products in the EU.

Biosimilars, also known as follow-on biologics or similar biological medicines, are highly similar versions of already-approved biologics medicines. Unlike generic pharmaceutical products, which must be identical to the reference listed drug, biosimilar products exhibit small differences due to manufacturing processes which affect the end product.

The changes are simple, but could have profound consequences for biosimilar and biologics manufacturers.

"Under the current European legal framework, companies developing a biosimilar medicine are required to identify a reference medicine that is or has been authorised in the EEA and whose batches are sourced from within the EEA," explained EMA in a 28 September statement explaining the move. "With the new approach, first announced by Commissioner John Dalli in Malta on 15 June 2012, the Agency will begin to accept reference medicine batches sourced from outside the EEA in certain pre-clinical and clinical studies in the comparability exercise."

Previously, companies would be required to re-conduct many of the same trials to show that the drug worked the same in EU patients as it did in US or foreign patients. This raised the costs of moving a biosimilar product to market considerably.

EMA said it had released a new guidance document to assist industry sponsors, which EMA said will be responsible for establishing that the foreign reference product is, "Representative of the reference medicines authorized in the EEA through an extensive analytical comparison." Data, and in particular pharmacokinetic and pharmacodynamic data, will likely be necessary to accomplish this, explained EMA.

EMA said it expects to start accepting foreign reference data sometime in 2013, though it said it would only do so after the conclusion of a process aimed at revising its existing guideline on similar biological medicinal products.

The move will help both companies and patients, said EMA, allowing for products to reach the market more quickly without requiring the costly and time-consuming process of replicating clinical trials. The US Food and Drug Administration (FDA) has said it plans to institute a similar plan once its draft guidance documents are finalized, potentially allowing for some degree of regulatory harmonization between the two bodies.


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